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Supprelin LA
Dosage Form: subcutaneous implant
FULL PRESCRIBING INFORMATION
Indications and Usage for Supprelin LA
SUPPRELIN LA (histrelin acetate) subcutaneous implant is indicated for the treatment of children with central precocious puberty (CPP).
Children with CPP (neurogenic or idiopathic) have an early onset of secondary sexual characteristics (earlier than 8 years of age in females and 9 years of age in males). They also show a significantly advanced bone age that can result in diminished adult height attainment.
Prior to initiation of treatment a clinical diagnosis of CPP should be confirmed by measurement of blood concentrations of total sex steroids, luteinizing hormone (LH) and follicle stimulating hormone (FSH) following stimulation with a GnRH analog, and assessment of bone age versus chronological age. Baseline evaluations should include height and weight measurements, diagnostic imaging of the brain (to rule out intracranial tumor), pelvic/testicular/adrenal ultrasound (to rule out steroid secreting tumors), human chorionic gonadotropin levels (to rule out a chorionic gonadotropin secreting tumor), and adrenal steroids to exclude congenital adrenal hyperplasia.
Supprelin LA Dosage and Administration
Recommended Dose
The recommended dose of Supprelin LA is one implant every 12 months. Each implant contains 50 mg histrelin acetate. The implant is inserted subcutaneously in the inner aspect of the upper arm and provides continuous release of histrelin (65 mcg/day) for 12 months of hormonal therapy. Supprelin LA should be removed after 12 months of therapy (the implant has been designed to allow for a few additional weeks of histrelin acetate release, in order to allow flexibility of medical appointments). At the time an implant is removed, another implant may be inserted to continue therapy. Discontinuation of Supprelin LA should be considered at the discretion of the physician and at the appropriate time point for the onset of puberty (approximately 11 years for females and 12 years for males).
Recommended Procedure for Implant Insertion and Removal
This procedure section is intended to provide guidance for the insertion and removal of Supprelin LA. The actual procedure used, however, is at the discretion of the qualified healthcare provider performing the procedure.
Insertion of a new implant can proceed using the following Suggested Insertion Procedure. If a previous Supprelin LA implant must first be removed, please see the Suggested Removal Procedure instructions below.
Suggested Insertion Procedure
The supplies necessary to insert the implant, including the Insertion Tool and local anesthetic, are provided in a separate Implantation Kit that is shipped along with the implant. Please note that the implant should be kept refrigerated (2-8°C) in its sealed vial, pouch, and carton, until needed for the procedure. Once removed from refrigeration, the vial containing the implant (still in its unopened pouch and carton) may remain at room temperature for up to 7 days, if necessary, before being used. If not used in that time, the packaged implant may again be properly refrigerated until the expiration date on the carton.
NOTE: The Implantation Kit is to be stored at room temperature and should not be refrigerated.
Insertion of the Supprelin LA implant is a surgical procedure. Sterile gloves and aseptic technique must be used to minimize any chance of infection.
Setting up the Sterile Field
Using proper aseptic technique, the sterilized components of the Implantation Kit needed for the insertion procedure, including the Insertion Tool, are to be carefully dispensed from their packaging onto the Sterile Field drape (non-fenestrated) provided. NOTE THAT THE KIT BOX AND ALL PACKAGING ARE NOT STERILE and should be kept off of the Sterile Field drape. DO NOT PLACE THE VIAL OF LOCAL ANESTHETIC OR THE VIAL CONTAINING THE IMPLANT ONTO THE DRAPE as the exterior surface of these vials is not sterile.
The implant vial should not be opened until just before the time of insertion. Open the vial by removing the metal band and carefully pour the sterile contents (implant and sterile saline) onto the Sterile Field drape. The implant can then be handled with sterile gloves or with the sterile mosquito clamp provided. AVOID bending or pinching the implant.
Preparing the Patient and the Insertion Site
The patient should be on his/her back, ideally with the arm least used (e.g., left arm for a right-handed person) positioned, either bent or extended, so that the physician has ready access to the inner aspect of the upper arm. Propping the arm with pillows may help the patient more easily hold the position. The suggested optimum site for subcutaneous insertion is approximately half-way between the shoulder and the elbow, in line with the crease between the biceps and triceps muscles.
Antiseptic
Swab the insertion area with topical antiseptic, then overlay with the fenestrated Sterile Field drape provided, so that the opening is over the insertion site (for clarity of illustration, the following images do not show the drape).
Anesthetic
The method of anesthesia utilized (i.e., local, conscious sedation, general) is at the discretion of the healthcare provider.
If local anesthesia is selected: a vial of sterile local anesthetic (note that the exterior of the vial is not sterile) has been provided along with a sterile hypodermic needle for injection. After determining the absence of known allergies to the anesthetic agent, inject anesthetic into the subcutaneous tissue, starting at the planned incision site, then infiltrating along the intended subcutaneous insertion path, up to the length of the implant (a little more than one inch). Local anesthesia may also be supplemented by the use of distraction techniques.
The following sections describe the suggested procedure for insertion of the implant using the Insertion Tool provided. The method of insertion used, however, is at the discretion of the healthcare provider performing the procedure.
Loading the Insertion Tool
The sterile Insertion Tool is comprised of a fixed handle attached to a retractable, bevel-tipped cannula, into the chamber of which the implant is to be placed for subcutaneous insertion. The cannula can be extended and retracted. The fully extended cannula contains a fixed piston upon which the implant, once inserted, rests. During the final step of the insertion procedure, the cannula will be retracted into the handle using the slide mechanism (green button), thereby exposing and leaving the implant to remain in the subcutaneous tissue.
When first grasping the sterile Insertion Tool, confirm that the cannula is fully extended. Verify this by inspecting the position of the green retraction button. The button should be locked in position all the way forward, towards the cannula, farthest from the handle.
The implant can be picked up using sterile gloves or with the sterile mosquito clamp provided. Avoid bending or pinching the implant. Note that the implant may come out of its vial slightly curved and/or partially flattended after refrigerated storage. To help make the implant more symmetrical prior to loading into the Tool, you can roll the implant a few times (while wearing a sterile glove) between the fingers and thumb.
Insert the implant into the cannula of the Insertion Tool manually or using the mosquito clamp. When inserting the implant into the cannula, DO NOT FORCE the implant. If resistance is felt, the implant should be removed and manually manipulated or rolled as needed, and re-inserted into the cannula.
When fully inserted, the implant rests inside the cannula so that just the tip of the implant is visible at the beveled end of the cannula.
Making the Incision
Using the sterile scalpel provided, make an incision transverse to the long axis of the arm, and of a size adequate to allow the bore of the cannula to be inserted into the subcutaneous tissue. Be sure that the incision is positioned so that there is sufficient length of upper arm available to fit the implant easily within the intended insertion space.
Inserting the Implant
It is suggested that insertion may be easier if a “pocket” for the implant is first created by blunt dissection through the incision, subcutaneously along the path of the anesthetic, using the cannula of the loaded Insertion Tool, or using a sterile hemostatic clamp or equivalent surgical tool.
Be sure to VISIBLY RAISE THE SKIN (known as tenting) at all times during the pocket-making and insertion procedures to ensure correct subcutaneous placement (“just under the skin”) of the implant. Note that the cannula of the Insertion Tool, or whatever tool is being used to create the pocket, SHOULD NOT ENTER MUSCLE TISSUE. Deep insertion of the implant will not affect the performance of Supprelin LA, but may cause difficulty in the later removal of the implant.
If using the cannula of the loaded Insertion Tool to create the pocket, carefully insert the tip of the cannula into the incision and advance through the subcutaneous tissue, while visibly raising the skin along the length of the cannula up to, but no farther than, the inscribed black line on the cannula. DO NOT DEPRESS THE GREEN RETRACTION BUTTON ON THE TOOL WHILE INSERTING OR ADVANCING THE TOOL INTO THE INCISION.
Pull the Tool back, almost to the beveled tip of the cannula, and advance the Tool forward again, so that the cannula re-enters the pocket completely, but no farther than the inscribed black line. Be sure to keep the insertion path just immediately subcutaneous.
If another tool was used to create the pocket, now insert the loaded cannula of the Insertion Tool containing the implant through the incision, up to the inscribed black line.
Hold the Insertion Tool in place with the base against the patient’s arm (if possible) as you carefully move your thumb to the green retraction button. Depress the button to release the locking mechanism, then slide the button back toward the handle until it stops, all the while holding the body of the Insertion Tool in place.
Retracting the button causes the cannula to withdraw from the incision, leaving the implant in the subcutaneous tissue. DO NOT FURTHER ADVANCE THE CANNULA ONCE THE RETRACTION PROCESS HAS STARTED. Likewise, do not withdraw the Insertion Tool until the button is fully retracted or the implant may be pulled partially out of the incision. Once the retraction is complete, the Tool can be fully withdrawn.
NOTE: It may be helpful during the process of retraction and withdrawal of the cannula to apply pressure to the skin over the implant, to help ensure that the implant remains in the subcutaneous pocket.
If there is a need to re-start the process at any time during the insertion procedure, withdraw the Insertion Tool, carefully extract the implant from the cannula and reset the retraction button on the Tool to its forward-most position. Examine the implant before reloading the implant into the Insertion Tool, and start again.
Placement of the implant should be confirmed by palpation. Note that the tip of a properly-placed implant may not be visible through the incision.
After implantation, briefly cover the site with a sterile gauze pad and apply pressure to ensure hemostasis.
Closing the Incision
To close the incision, you can use the absorbable sutures and/or the sterile adhesive surgical strips provided. To improve adhesion of the strips, you can apply benzoin tincture antiseptic (provided) to the skin, and let it dry, before applying the adhesive strips.
Once closed, cover the incision site with sterile gauze pads and secure the dressing with the bandage provided.
Please provide the patient’s parent or guardian with a Patient Information Leaflet, which includes information about the implant and instructions on proper care of the insertion site.
Suggested Removal Procedure
SUPPRELIN LA should be removed after 12 months of therapy. Most of the supplies necessary to remove the implant, including the local anesthetic and the sterile mosquito clamp, are provided in the Implantation Kit that is shipped along with a new Supprelin LA implant. Note that the Implantation Kit is to be stored at room temperature and must not be refrigerated. See the Suggested Insertion Procedure above for further instructions.
Removal of the Supprelin LA implant is a surgical procedure. Sterile gloves and aseptic technique must be used to minimize any chance of infection.
Setting up the Sterile Field
Using proper aseptic technique, the sterilized components of the Implantation Kit needed for the implant removal procedure are to be carefully dispensed from their packaging out onto the Sterile Field drape (non-fenestrated) provided. NOTE THAT THE KIT BOX AND ALL PACKAGING ARE NOT STERILE and should be kept off of the Sterile Field drape. DO NOT PLACE THE VIAL OF LOCAL ANESTHETIC ONTO THE DRAPE as the exterior surface of the vial is not sterile.
Preparing the Patient and the Site
The patient should be on his/her back, with the arm containing the implant positioned, either bent or extended, so that the physician has ready access to the inner aspect of the upper arm. Propping the arm with pillows may help the patient more easily hold the position.
The implant to be removed should first be located by palpating the inner aspect of the upper arm, near the incision from the prior year.
Generally, the previous implant is readily palpated. In the event the implant is difficult to locate, ultrasound may be used. If ultrasound fails to locate the implant, other imaging techniques such as CT or MRI may be used to locate it (plain films are not recommended as the implant is not radiopaque).
Antiseptic
Swab the area above and around the previous implant with topical antiseptic. Overlay the area with the fenestrated Sterile Field drape provided, so that the hole is over the previous insertion site (for clarity of illustration, the following images do not show the drape).
Anesthetic
The method of anesthesia utilized (i.e., local, conscious sedation, general) is at the discretion of the healthcare provider.
If local anesthesia is selected: a vial of sterile local anesthetic (note that the exterior of the vial is not sterile) has been provided along with a sterile hypodermic needle for injection. After determining the absence of known allergies to the anesthetic agent, inject anesthetic into the subcutaneous tissue at and around the site of the intended incision (the site of the previous implant). Local anesthesia may also be supplemented by the use of distraction techniques.
Making the Incision and Removing the Implant
Using the sterile scalpel provided, make an incision of a size adequate to allow the implant to be easily removed and, if a new implant will be inserted, large enough for the bore of the cannula of the Insertion Tool provided.
Generally, the tip of the implant will be visible through the incision, possibly covered by a pseudocapsule of tissue. In order to facilitate the removal of the implant, it may be necessary to palpate the head of the implant through the incision using your smallest finger, especially if the head of the implant is not readily visible. In addition, you may need to push down on the distal end of the implant and “massage it forward” towards the incision.
Carefully nick the pseudocapsule to reveal the polymer tip of the implant. It may be beneficial to insert the sterile mosquito clamp provided into the hole created in the pseudocapsule and expand by opening the clamp. Widening the opening of the pseudocapsule may ease the extraction of the implant.
Gently but securely grasp the implant with the sterile mosquito clamp and extract the implant.
Dispose of the implant in a proper manner, treating it like any other bio-waste.
Briefly cover the site with a sterile gauze pad and apply pressure to ensure hemostasis.
If inserting a new implant, see the Suggested Insertion Procedure instructions provided above. Note that you can insert the new implant into the same “pocket” as the removed implant, or make a new incision at a different site in the same arm or in the contralateral arm.
If a new implant is not to be inserted, proceed to close the incision.
Closing the Incision
To close the incision, you can use the absorbable sutures and/or the sterile adhesive surgical strips provided. To improve adhesion of the strips, you can apply benzoin tincture antiseptic (provided) to the skin, and let it dry, before applying the adhesive strips.
Once closed, cover the incision site with sterile gauze pads and secure the dressing with the bandage provided.
Dosage Forms and Strengths
SUPPRELIN LA is a sterile, nonbiodegradable, diffusion-controlled, MedLaunch™ polymer (also known as a “hydrogel”) reservoir drug delivery system designed to deliver histrelin acetate continuously for 12 months after subcutaneous implantation. The sterile implant contains 50 mg histrelin acetate and delivers approximately 65 mcg histrelin acetate per day over 12 months.
Contraindications
Supprelin LA is contraindicated in patients who are hypersensitive to gonadotropin releasing hormone (GnRH) or GnRH agonist analogs.
Supprelin LA is contraindicated in females who are or may become pregnant while receiving the drug. Supprelin LA may cause fetal harm when administered to pregnant patients. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. The possibility exists that spontaneous abortion may occur [see Use in Specific Populations (8.1)].
Warnings and Precautions
Initial Agonistic Action
SUPPRELIN LA, like other GnRH agonists, initially causes a transient increase in serum concentrations of estradiol in females and testosterone in both sexes during the first week of treatment. Patients may experience worsening of symptoms or onset of new symptoms during this period. However, within 4 weeks of histrelin therapy, suppression of gonadal steroids occurs and manifestations of puberty decrease.
Implant Insertion/Removal Procedure
Implant insertion is a surgical procedure and it is important that the insertion instructions are followed to avoid potential complications. The insertion and removal of the implant should be done aseptically. Proper surgical technique is critical in minimizing adverse events related to the insertion and the removal of the histrelin implant. On occasion, localizing and/or removal of implant products have been difficult and imaging techniques were used, including ultrasound, CT, or MRI (note: the histrelin implant is not radiopaque). Rare events of spontaneous extrusion of the implant have been observed in clinical trials. During Supprelin LA treatment, patients should be evaluated for evidence of clinical and biochemical suppression of CPP manifestations (see Section 5.3, Monitoring and Laboratory tests). Detailed instructions on the insertion and removal procedures of the implant are provided above [see Dosage and Administration (2.2)].
Monitoring and Laboratory Tests
LH, FSH and estradiol or testosterone should be monitored at 1 month post implantation then every 6 months thereafter. Additionally, height (for calculation of height velocity) and bone age should be assessed every 6-12 months.
Adverse Reactions
Overall Adverse Reaction Profile
The most common adverse reactions with Supprelin LA involved the implant site. Local reactions after implant insertion include bruising, pain, soreness, erythema and swelling.
During the early phase of therapy, gonadotropins and sex steroids rise above baseline because of the natural stimulatory effect of the drug. Therefore, an increase in clinical signs and symptoms may be observed [see Warnings and Precautions (5.1)].
Adverse Reactions in Clinical Trials
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of Supprelin LA in children with CPP was evaluated in two single-arm clinical trials conducted in a total of 47 patients (44 females and 3 males) over a period of time ranging from 9 to 18 months. The most commonly reported adverse reaction was implant site reaction, which was reported by 24 of 47 (51.1%) patients. Implant site reaction includes discomfort, bruising, soreness, pain, tingling, itching, implant area protrusion and swelling. Two subjects experienced a serious adverse reaction: 1 subject who coincidentally had Stargardt’s Disease experienced amblyopia and 1 subject had a benign pituitary tumor (pituitary adenoma). One subject discontinued the study due to an adverse reaction of infection at the implant site. There were no clinically meaningful findings in standard clinical hematology and chemistry tests and/or in vital signs. The incidence of implantation adverse events reported by more than 2 patients are summarized in Table 1.
| Adverse Reactions | N=47 N (%) |
| Implant site reaction | 24 (51.1) |
| Keloid scar | 3 (6.4) |
| Scar | 3 (6.4) |
| Suture related complication | 3 (6.4) |
| Application site pain | 2 (4.3) |
| Post procedural pain | 2 (4.3) |
The following adverse reactions were reported as possibly related or related in 1 patient each: wound infection, breast tenderness, dysmenorrhea, epistaxis, erythema, feeling cold, gynecomastia, headache, menorrhagia, migraine, mood swings, pituitary tumor benign, pruritus, weight increased, disease progression and influenza-like illness. The adverse reaction metrorrhagia was reported as possibly related or related in 2 patients.
Drug Interactions
Overview: No formal drug-drug, drug-food, or drug-herb interaction studies were performed with Supprelin LA.
Drug-Laboratory Interactions: Therapy with Supprelin LA results in suppression of the pituitary-gonadal system. Results of diagnostic tests of pituitary gonadotropic and gonadal functions conducted during and after Supprelin LA therapy may be affected. Supprelin LA decreased mean serum insulin-like growth factor-1 (IGF-1) levels by approximately 11% in one study (Study 1). Supprelin LA increased the serum concentration of dehydroepiandrosterone (DHEA) in 8 of 36 patients in another study (Study 2).
USE IN SPECIFIC POPULATIONS
Pregnancy
Pregnancy category X [see Contraindications (4)].
SUPPRELIN LA is contraindicated in females who are, or may become, pregnant while receiving the drug. Supprelin LA can cause fetal harm when administered to a pregnant patient. The possibility exists that spontaneous abortion may occur.
Animal Data: Major fetal abnormalities were observed in rabbits at 3 times human therapeutic exposure but not in rats after administration of histrelin acetate throughout gestation. There was dose-related increased fetal mortality during organogenesis in both rats given 1, 3, 5 or 15 mcg/kg/day (at less than therapeutic exposures using body surface area comparisons, based on a 65 mcg per day human dose) and in rabbits at 20, 50 or 80 mcg/kg/day (at 3 times human exposure using body surface area comparisons, based on a 65 mcg/day dose in humans).
Pediatric Use
Safety and effectiveness in pediatric patients below the age of 2 years have not been established. The use of Supprelin LA in children under 2 years is not recommended.
Overdosage
There have been no reports of overdose in Supprelin LA clinical trials. High doses of histrelin acetate injection in animal studies were generally associated only with effects attributed to the expected pharmacology. The method of drug delivery makes accidental or intentional overdosage unlikely.
Supprelin LA Description
SUPPRELIN LA is a sterile, non-biodegradable, diffusion-controlled, MedLaunch™ polymer reservoir containing histrelin acetate, a synthetic nonapeptide analog of the naturally occurring gonadotropin releasing hormone (GnRH) possessing a greater potency than the natural sequence hormone. Supprelin LA is designed to deliver approximately 65 mcg histrelin acetate per day over 12 months.
The Supprelin LA implant looks like a small thin flexible tube and consists of a 50-mg histrelin acetate drug core inside a 3.5 cm by 3 mm, cylindrical, MedLaunch™ polymer reservoir (Figure 1). The implant may appear partially to completely full with variation in color from off-white to light brown. The color may be uneven within the core.
Figure 1. Supprelin LA Implant Diagram (not to scale)
The chemical name of histrelin acetate is: L - Pyroglutamyl - L - histidyl - L - tryptophyl - L - seryl - L - tyrosyl - N - benzyl - D - histidyl - L - leucyl - L - arginyl - L - proline N-ethylamide, acetate salt.
The molecular formula for histrelin acetate is C66H86N18O12 x 2 CH3COOH and its molecular weight is 1443.70 (or 1323.52 as free base). Histrelin is also chemically described as 5 - oxo - L - prolyl - L - histidyl - L - tryptophyl - L - seryl - L - tyrosyl - Nt - benzyl - D - histidyl - L - leucyl - L - arginyl - N - ethyl - L - prolinamide diacetate. The chemical structure of the free base (histrelin) is represented below in Figure 2.
Figure 2. Structure of Histrelin
The drug core also contains the inactive ingredient stearic acid NF. The MedLaunch™ polymer reservoir is a hydrophilic cartridge composed of 2-hydroxyethyl methacrylate, 2-hydroxypropyl methacrylate, trimethylolpropane trimethacrylate, benzoin methyl ether, Perkadox-16, and Triton X-100. Each implant is packaged hydrated in a glass vial containing 2 mL of sterile 1.8% sodium chloride solution, so that it is primed for immediate release of the drug upon insertion.
A single use, sterile, Insertion Tool is provided along with the implant that can be used for the placement of the Supprelin LA implant into the subcutaneous tissue of the inner aspect of the upper arm. The Insertion Tool is enclosed in a sterile bag and is provided separately from the implant in the Implantation Kit [see Recommended Procedure for Implant Insertion and Removal (2.2)].
Supprelin LA - Clinical Pharmacology
Mechanism of Action
SUPPRELIN LA is a GnRH agonist and an inhibitor of gonadotropin secretion when given continuously. It delivers approximately 65 mcg histrelin acetate per day. Both animal and human studies indicate that following an initial stimulatory phase, chronic, subcutaneous administration of histrelin acetate desensitizes responsiveness of the pituitary gonadotropin which, in turn causes a reduction in ovarian and testicular steroidogenesis.
In humans, administration of histrelin acetate results in an initial increase in circulating levels of LH and FSH, leading to a transient increase in concentration of gonadal steroids (testosterone and dihydrotestosterone in males, and estrone and estradiol in premenopausal females).
However, continuous administration of histrelin acetate causes a reversible down-regulation of the GnRH receptors in the pituitary gland and desensitization of the pituitary gonadotropes. These inhibitory effects result in decreased levels of LH and FSH.
Pharmacodynamics
Long-term treatment with histrelin acetate suppresses the LH response to GnRH causing LH levels to decrease to prepubertal levels within 1 month of treatment. As a result, serum concentrations of sex steroids (estrogen or testosterone) also decrease. Consequently, secondary sexual development ceases to progress in most patients. Additionally, linear growth velocity is slowed which improves the chance of attaining predicted adult height.
Pharmacokinetics
Pharmacokinetics of histrelin acetate after implantation of Supprelin LA was evaluated in a total of 47 children with CPP (11 subjects in Study 1 and 36 subjects in Study 2). Patients were examined at 4 weeks after implant insertion and a few times throughout the treatment period. Median serum histrelin concentrations remained above the limit of quantification for the treatment period. Histrelin acetate levels were sustained throughout the study period for most subjects (Figure 3). The median of maximum serum histrelin concentrations over the study period was 0.43 ng/mL, which is expected to maintain gonadotropins at prepubertal levels. There was no apparent pharmacokinetic difference between naïve subjects to a LHRH agonist treatment and subjects who had previous treatment with a LHRH agonist (Figure 3).
Figure 3. Mean and Standard Deviation of Serum Histrelin Concentrations (ng/mL) Results at Each Visit
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies were conducted in rats for 2 years at doses of 5, 25 or150 mcg/kg/day (up to 11 times human exposures using body surface area comparisons, based on a 65 mcg/day dose in humans) and in mice for 18 months at doses of 20, 200, or 2000 mcg/kg/day (at less than therapeutic exposure to 70 times human exposure using body surface area comparisons, based on a 65 mcg/day dose in humans). As seen with other GnRH agonists, histrelin injection administration was associated with an increase in tumors of hormonally responsive tissues. There was a significant increase in pituitary adenomas in rats at mid and high doses (2-11 times human exposure based on body surface area comparisons with a 65 mcg/day human dose). There was an increase in pancreatic islet-cell adenomas in treated female rats and a non-dose-related increase in testicular Leydig-cell tumors (highest incidence in the low-dose group). In mice, there was significant increase in mammary-gland adenocarcinomas in all treated females. In addition, there were increases in stomach papillomas in male rats given high doses, and an increase in histiocytic sarcomas in female mice at the highest dose.
Mutagenicity studies have not been performed with histrelin acetate. Saline extracts of implants with and without histrelin acetate were negative in a battery of genotoxicity studies. Fertility studies have been conducted in rats and monkeys given subcutaneous daily doses of histrelin acetate up to 180 mcg/kg/day (up to 13 and 30 times human exposure, respectively using body surface area comparisons, based on a 65 mcg/day human dose) for 6 months and full reversibility of fertility suppression was demonstrated. The development and reproductive performance of offspring from parents treated with histrelin acetate has not been investigated.
Clinical Studies
The efficacy of Supprelin LA in children with CPP has been evaluated in two single-arm, open label studies. Study 1 was conducted in 11 pretreated female patients, 3.7 to 11.0 years of age. Study 2 was conducted in 36 patients (33 females and 3 males), 4.5 to 11.6 years of age. Sixteen pretreated and 20 treatment-naïve patients were enrolled in Study 2. Baseline patient characteristics were typical of patients with CPP. Efficacy assessments were similar in both studies and included endpoints that measured the suppression of gonadotropins (luteinizing hormone and follicle stimulating hormone) and gonadal sex steroids (estrogen in girls and testosterone in boys, respectively) on treatment. Other assessments were clinical (evidence of stabilization or regression of signs of puberty) or gonadal steroid-dependent (bone age, linear growth). In Study 2, the primary measure of efficacy was LH suppression.
In Study 2, suppression of LH was induced in all treatment naïve subjects and maintained in all pretreated subjects at Month 1 after implantation and continued through Month 12 (suppression was defined as a peak LH < 4 mIU/mL following stimulation with the GnRH analog leuprolide acetate).
Secondary efficacy hormone assessments (FSH, estradiol and testosterone) and additional efficacy assessments (bone age advancement, linear growth, clinical progression of puberty) indicated stabilization of disease. Estradiol suppression was present in all 33 girls (100%) through Month 9 and 97% at Month 12. Testosterone suppression was maintained in the three pre-treated males participating in Study 2. The Supprelin LA effect on efficacy endpoints in the Study 1 was consistent with that observed in Study 2.
How Supplied/Storage and Handling
Supprelin LA (NDC 67979-002-01) is supplied in a corrugated shipping carton that contains 2 inner cartons: a small one for the vial containing the Supprelin LA implant, which is shipped with a cold pack inside a polystyrene cooler that must be refrigerated upon arrival, and a larger one comprising the Implantation Kit, which must not be refrigerated, for use during insertion or removal of Supprelin LA.
The Supprelin LA implant contains 50 mg of histrelin acetate. The Supprelin LA implant carton contains a cold pack for refrigerated shipment and a small carton containing an amber plastic pouch. Inside the pouch is a glass vial with a Teflon-coated stopper and an aluminum seal, containing the implant in 2 mL of sterile 1.8% sodium chloride solution. (Note: The 3.5 mL vial is not completely filled with saline).
Upon receipt, refrigerate the small carton containing the amber plastic pouch and glass vial (with the implant inside) until the day of insertion. The implant vial should not be opened until just before the time of insertion.
SUPPRELIN LA is stable when stored refrigerated, in its sealed vial, pouch, and carton, at 2-8°C (36-46°F) until the expiration date provided. Excursion permitted to 25°C (77°F) for 7 days. Do not freeze. Protect from light.
Patient Counseling Information
See FDA-Approved Patient Labeling
Initial Agonistic Action
Patients should be advised that a transient worsening of symptoms of puberty or onset of new symptoms may occur initially. However, within 4 weeks of histrelin therapy, complete suppression of gonadal steroids occurs and manifestations of puberty decrease [see Warnings and Precautions (5.1)].
Post-insertion Care
Patients should be instructed to refrain from getting the inserted arm wet for 24 hours and from strenuous exertion of the inserted arm for 7 days after implant insertion to allow the incision to fully close. The adhesive elastic bandage can be removed at that time. The patient should not remove the surgical strips; rather, the strips should be allowed to fall off on their own after several days.
Common Adverse Reactions
Patients should be advised to report to their physician any severe pain, redness, or swelling in and around the implant site. Infrequently, Supprelin LA may be expelled from the body through the original incision site, rarely without the patient noticing. The patient should be instructed to monitor the incision site until it is healed. The patient should also return for routine checks of their condition and to ensure that Supprelin LA is present and functioning in his/her body [see Warnings and Precautions (5.2, 5.3)].
FDA-Approved Patient Labeling
SUPPRELIN® LA [Suh-Preh-Lin El-Ay]
(histrelin acetate) subcutaneous implant
Read the Patient Information that comes with Supprelin LA before your child begins treatment. This information does not take the place of talking with your child’s doctor about their medical condition or treatment.
What is SUPPRELIN LA?
SUPPRELIN LA is an under-the-skin (subcutaneous) implant that contains the medicine histrelin, a gonadotropin releasing hormone (GnRH). Supprelin LA is used for treatment of children with central precocious puberty (CPP).
CPP makes puberty come early in girls (before 8 years of age) and in boys (before 9 years of age). Signs of early puberty include breast enlargement in girls and the appearance of hair in the genital area in boys and girls. Supprelin LA works by reducing the amount of sex hormones in the blood to delay early puberty.
Who should not use Supprelin LA?
Your child should not use Supprelin LA if he/she is allergic to gonadotropin releasing hormone (GnRH), GnRH agonist medicines, or anything in the Supprelin LA implant. Supprelin LA should not be used in:
- children under 2 years of age
- women who are or may become pregnant (Supprelin LA can cause birth defects or loss of the baby).
How is Supprelin LA used?
- Your child’s doctor should do tests to make sure your child has CPP before treating your child with Supprelin LA.
- SUPPRELIN LA lasts for 12 months. One implant provides the medicine for 12 months. After 12 months, Supprelin LA must be removed. The doctor may insert a new Supprelin LA at this time to continue treatment.
- SUPPRELIN LA is placed under the skin of the inside of the upper arm. The doctor will temporarily numb the arm of your child, make a small cut, and then place Supprelin LA under the skin. The cut may be closed with stitches or surgical strips and covered with a pressure bandage.
- Your child should keep the arm clean and dry and should not swim or bathe for 24 hours. The bandage can be removed after 24 hours. Do not remove any surgical strips. They will fall off on their own in several days.
- Your child should avoid heavy play or exercise that uses the implanted arm for 7 days. After the cut has healed, your child can go back to his or her normal activities. The doctor will give you complete instructions.
- Keep all scheduled visits to the doctor. Your child’s doctor will do regular exams and blood tests to check for signs of puberty. Sometimes the doctor will have to do special examinations, such as ultrasound or MRI, if the Supprelin LA implant is difficult to find under your child’s skin.
What are the possible side effects of Supprelin LA?
In the first few weeks of treatment, Supprelin LA can cause a brief increase in some hormones, and during this time you may notice more signs of puberty in your child, including light vaginal bleeding and breast enlargement in girls. Within 4 weeks of treatment, you should see signs in your child that puberty is stopping.
- The most common side effects of Supprelin LA are skin reactions at the place where the implant is inserted. Such reactions may include bruising, soreness, pain, tingling, itching, and swelling. They usually go away without treatment within 2 weeks. Call your child’s doctor if your child has bleeding, redness or pain at the insertion site.
- Serious and life-threatening allergic reactions have happened with GnRH medicines (the type of medicine in Supprelin LA).
These may not be all the side effects of Supprelin LA. Ask your child’s doctor for more information.
General information about Supprelin LA
This patient labeling summarizes the most important information about Supprelin LA. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Supprelin LA that is written for health professionals.
For more information, call 1-800-462-3636 or visit www.supprelinla.com
Manufactured by:
Endo Pharmaceuticals Solutions Inc.
Chadds Ford, PA 19317 USA
MedLaunch™ is a Trademark of Endo Pharmaceuticals Inc.
Supprelin® is a Registered Trademark of Endo Pharmaceuticals Solutions Inc.
© 2011 Endo Pharmaceuticals
PK000033 Rev. 06
Supprelin LA
Package Label - Principal Display Panel - Vial Label
NDC 67979-002-01
Supprelin® LA (histrelin acetate) Subcutaneous implant
50 mg
Rx Only
Contains one sterile implant.
Usual Dosage: One implant every 12 months.
See package insert for full prescribing information.
Store at 2°-8°C (36°-46°F). Protect from light.
Manufactured by:
Endo Pharmaceuticals Solutions Inc.
Chadds Ford, PA 19317
PK000032 Rev. 02
Package Label - Principal Display Panel - Vial Carton
Top Flap:
Supprelin® LA (histrelin acetate) Subcutaneous implant
50 mg
PK000036 Rev. 02
Panels 1 and 3:
NDC 67979-002-01
Supprelin® LA (histrelin acetate) Subcutaneous implant
50 mg
The sterile Supprelin® LA implant consists of a 50-mg histrelin acetate drug core inside a non-
biodegradable, 3.5 cm by 3 mm, cylindrical HYDRON® polymer reservoir. The drug core also contains
the inactive ingredient stearic acid NF.
The HYDRON® polymer reservoir is composed of 2-hydroxyethyl methacrylate, 2-hydroxyropyl
methacrylate, trimethylolpropane trimethacrylate, benzoin methyl ether, Perkadox-16, and Triton X-
100.
Each implant is packaged in a glass vial containing 2 mL of 1.8% sodium chloride, sterile. Each vial is
enclosed in an opaque plastic pouch.
Do not use if the seal on the glass vial is broken.
Supprelin® LA and HYDRON® are registered trademarks of Endo Pharmaceuticals
Panel 3: Endo logo
Panels 2 and 4:
NDC 67979-002-01
Supprelin® LA (histrelin acetate) Subcutaneous implant
50 mg Rx Only
Sterile for Subcutaneous Use
Usual Dosage:
One implant every 12 months.
See package insert for full prescribing information.
Must be refrigerated. Do not freeze.
Store at 2°-8°C (36°-46°F). Protect from light.
Keep out of the reach of children.
Manufactured by:
Endo Pharmaceuticals Solutions Inc.
Chadds Ford, PA 19317
Panel 4: Bar Code – N3 67979 00201 6
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Gentamicin Sulfate eent
Class: Antibacterials
VA Class: AM300
CAS Number: 1405-41-0
Brands: Gentak, Pred-G
Introduction
Antibacterial; aminoglycoside antibiotic produced by Micromonospora purpurea.a b c d e
Uses for Gentamicin Sulfate
Bacterial Ophthalmic Infections
Treatment of superficial infections of the eye caused by susceptible bacteria.a b c
Used alone or in fixed combination with a topical corticosteroid (e.g., prednisolone) when such combination therapy is indicated.d e (See Use of Fixed Combinations Containing Corticosteroids under Cautions.)
Gentamicin Sulfate Dosage and Administration
Administration
Ophthalmic Administration
Apply topically to the eye(s) as an ophthalmic solution, suspension, or ointment.a b c d e
Not for injection into the eye; do not inject subconjunctivally or instill directly into the anterior chamber of the eye.a b c d
Avoid contamination of the tip of the container.102 c d e
Shake suspension well prior to use.d
Dosage
Available as gentamicin sulfate and as fixed combinations containing prednisolone acetate; dosage expressed in terms of gentamicin.b c d e
Pediatric Patients
Bacterial Ophthalmic Infections
Gentamicin Sulfate 0.3%
Ophthalmic Solution
Infants and children >1 month of age: 1 or 2 drops into the affected eye(s) every 4 hours.c
Infants and children >1 month of age: For severe infections, instill up to 2 drops into the affected eye(s) every hour.c
Ophthalmic Ointment
Infants and children >1 month of age: Apply a 1.25-cm ribbon to the affected eye(s) 2 or 3 times daily.b
Adults
Bacterial Ophthalmic Infections
Gentamicin Sulfate 0.3%
Ophthalmic Solution
1 or 2 drops into the affected eye(s) every 4 hours.c
Severe infections: Instill up to 2 drops into the affected eye(s) every hour.c
Ophthalmic Ointment
Apply a 1.25-cm ribbon to the affected eye(s) 2 or 3 times daily.b
Gentamicin Sulfate 0.3% and Prednisolone Acetate 0.6%
If improvement does not occur after 2 days, reevaluate the patient.d e
Do not discontinue therapy prematurely.d e
Ophthalmic Solution
Initial 24–48 hours, up to 1 drop into the conjunctival sac of the affected eye(s) every hour; thereafter, 1 drop 2–4 times daily.d
Ophthalmic Ointment
Apply a 1.25-cm ribbon into the conjunctival sac of the affected eye(s) 1–3 times daily.e
Cautions for Gentamicin Sulfate
Contraindications
Known hypersensitivity to gentamicin or any ingredient in the formulation.a b c d e
Warnings/Precautions
Sensitivity Reactions
Sensitization may occur.a b c d e Discontinue if hypersensitivity reaction occurs.a b c
Commercially available gentamicin preparations contain other ingredients (e.g., parabens), which may cause allergic contact dermatitis.a (See Preparations.)
Cross-allergenicity
Cross-allergenicity occurs among the aminoglycosides.a
General Precautions
Superinfection
Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi.a b c d e If superinfection occurs, discontinue drug and institute appropriate therapy.a
Use of Fixed Combinations Containing Corticosteroids
Topical corticosteroids may mask clinical signs of bacterial, fungal, or viral infections or may suppress hypersensitivity reactions to gentamicin or other ingredients in the formulation.a
When gentamicin is used in fixed combination with a corticosteroid, consider the cautions, precautions, and contraindications associated with EENT corticosteroids.a d e
Infection Complications
Ophthalmic ointments may delay corneal healing.b
Bacterial and fungal corneal ulcers possible during treatment.b c
Specific Populations
Pregnancy
Category C.b c d e
Lactation
Systemic gentamicin is distributed into breast milk.g Gentamicin in fixed combination with prednisolone acetate (ophthalmic suspension and ophthalmic ointment): Discontinue nursing or the drug.d e
Pediatric Use
Safety and efficacy of gentamicin ophthalmic solution and ophthalmic ointment not established in neonates.b c
Safety and efficacy of gentamicin in fixed combination with prednisolone acetate (ophthalmic suspension and ophthalmic ointment) not established.d e
Geriatric Use
Gentamicin in fixed combination with prednisolone acetate (ophthalmic suspension and ophthalmic ointment): No substantial differences in safety or efficacy relative to younger patients.d e
Common Adverse Effects
Transient irritation, burning, stinging.a b c d
Gentamicin Sulfate Pharmacokinetics
Absorption
Extent
Absorption is greatest when the cornea is abraded.a
Distribution
Extent
Systemic gentamicin crosses the placenta and is distributed into breast milk.g
Stability
Storage
Ophthalmic
Ointment
Gentamicin: 2–30°C.b
Gentamicin in fixed combination with prednisolone acetate: 15–25°C.e
Solution
Gentamicin: 2–30°C; avoid excessive heat.c
Suspension
Gentamicin in fixed combination with prednisolone acetate: 15–25°C.d Do not freeze; avoid excessive heat (≥40°C).d
Actions and SpectrumActions
Usually bactericidal in action.a
Mechanism of action not fully elucidated; however, appears to inhibit protein synthesis in susceptible bacteria by irreversibly binding to 30S ribosomal subunits.a
Active against many aerobic gram-negative and some aerobic gram-positive bacteria.a b c Inactive against fungi, viruses, and most anaerobic bacteria.a
Natural and acquired resistance to gentamicin demonstrated in both gram-negative and gram-positive bacteria.a Resistance to other aminoglycosides and several other anti-infectives (e.g., chloramphenicol, sulfonamides, tetracycline) may be transferred on the same plasmid.a
Partial cross-resistance between gentamicin and other aminoglycosides.a
Advice to Patients
Importance of removing soft contact lenses prior to administering preparations containing benzalkonium chloride and of delaying reinsertion of the lenses for ≥5 minutes after administration.f
Importance of not touching tip of container to the eye, eyelid, fingers, or any other surface to avoid contamination.a b c
Importance of discontinuing therapy and contacting clinician if the infection worsens or does not improve, or if any signs of sensitivity occur (discharge, swelling, pain).b c
Advise patient not to share the drug with any other person.d
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.b c
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.b c
Importance of informing patients of other important precautionary information. (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Ophthalmic | Ointment | 0.3% (of gentamicin) | Gentak (with parabens) | Akorn |
Gentamicin Sulfate | Fougera | |||
Solution | 0.3% (of gentamicin)* | Gentak (with benzalkonium chloride) | Akorn | |
Gentamicin Sulfate | Bausch & Lomb, Falcon |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Ophthalmic | Ointment | Gentamicin Sulfate 0.3% (of gentamicin) and Prednisolone Acetate 0.6% | Pred-G (with chlorobutanol 0.5%) | Allergan |
Suspension | Gentamicin Sulfate 0.3% (of gentamicin) and Prednisolone Acetate 1% | Pred-G (with benzalkonium chloride; viscous) | Allergan |
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Gentak 0.3% Ointment (AKORN): 3/$21.99 or 7/$35.98
Gentamicin Sulfate 0.3% Solution (FALCON PHARMACEUTICALS): 5/$25.99 or 10/$45.98
Pred-G 0.3-1% Suspension (ALLERGAN): 5/$39.35 or 15/$101.19
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
References
101. Akorn. Gentamicin sulfate ophthalmic solution USP, 0.3% prescribing information. Buffalo Grove, IL; 2002 Jan.
102. Akorn. Gentamicin sulfate ophthalmic ointment USP, 0.3% prescribing information. Somerset, NJ; 1998 Jul.
103. Allergan. Pred-G (gentamicin and prednisolone acetate ophthalmic suspension, USP) 0.3%/1% prescribing information. In: Physicians’ desk reference for ophthalmic medicines. 34th ed. Montevale, NJ: Thomson PDR; 2006: 234-5.
104. American Academy of Ophthalmology. Preferred Practice Pattern: Conjunctivitis. 2003. From the American Academy of Ophthalmology website (http://www.aao.org) Accessed 11 May 2006.
a. AHFS drug information 2008. McEvoy, GK, ed. Gentamicin sulfate (ophthalmic). Bethesda, MD: American Society of Health-System Pharmacists; 2008:2845-6.
b. Akorn, Inc. gentamicin sulfate ophthalmic ointment USP 0.3% prescribing information. Buffalo Grove, IL; 2008 Feb.
c. Akorn, Inc. Gentamicin sulfate ophthalmic solution USP 0.3% prescribing information. Buffalo Grove, IL; 2006 Oct.
d. Allergan, Inc. Pred-G (gentamicin and prednisolone acetate) ophthalmic suspension USP 0.3%/1.0% prescribing information. Irvine, CA; 2005 Dec.
e. Allergan, Inc. Pred-G (gentamicin and prednisolone acetate) ophthalmic ointment USP 0.3%/0.6% prescribing information. Irvine, CA; 2004 Jan.
f. Christensen MT, Barry JR, Turner FD. Five-minute removal of soft lenses prevents most absorption of a topical ophthalmic solution. CLAO J. 1998; 24:227-231. [PubMed 9800062]
g. Briggs GG, Freeman RK, Yaffe SJ. Drugs in Pregnancy and lactation, 7th ed. Lippincott Williams & Wilkins: Philadelphia, PA; 2005:720-22.
More Gentamicin Sulfate eent resources
- Gentamicin Sulfate eent Use in Pregnancy & Breastfeeding
- Gentamicin Sulfate eent Support Group
- 0 Reviews for Gentamicin Sulfate eent - Add your own review/rating
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- Conjunctivitis, Bacterial
Monday, October 24, 2016
Priom-D
Priom-D may be available in the countries listed below.
Ingredient matches for Priom-D
Domperidone
Domperidone is reported as an ingredient of Priom-D in the following countries:
- India
Omeprazole
Omeprazole is reported as an ingredient of Priom-D in the following countries:
- India
International Drug Name Search
Furaltadone
In some countries, this medicine may only be approved for veterinary use.
Scheme
Rec.INN
CAS registry number (Chemical Abstracts Service)
0000139-91-3
Chemical Formula
C13-H16-N4-O6
Molecular Weight
324
Therapeutic Category
Antiinfective
Chemical Name
2-Oxazolidinone, 5-(4-morpholinylmethyl)-3-[[(5-nitro-2-furanyl)methylene]amino]-
Foreign Names
- Furaltadonum (Latin)
- Furaltadon (German)
- Furaltadone (French)
- Furaltadona (Spanish)
Generic Names
- Furaltadone (OS: BAN)
- Furmethonol (IS)
- Megafur (IS)
- Neofur (IS)
- Spectrafur (IS)
- Unifur (IS)
- Furaltadone pour usage vétérinaire (PH: Ph. Franç. Xe édit)
Brand Names
- Tabernil Cria (Furaltadone and Chlortetracycline, + Neomycin (veterinary use))
Divasa Farmavic de Portugal, Lda, Portugal - Trefurcan (Furaltadone and Neomycin (veterinary use))
Sogeval, France
International Drug Name Search
Glossary
| BAN | British Approved Name |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Click for further information on drug naming conventions and International Nonproprietary Names.
Lisinopril Edigen
Lisinopril Edigen may be available in the countries listed below.
Ingredient matches for Lisinopril Edigen
Lisinopril
Lisinopril dihydrate (a derivative of Lisinopril) is reported as an ingredient of Lisinopril Edigen in the following countries:
- Spain
International Drug Name Search
Acidex, Compound Alginate Oral Suspension, Heartburn and Indigestion Liquid
1. Name Of The Medicinal Product
Acidex, Compound Alginate Oral Suspension, Heartburn and Indigestion Liquid
Compound Alginate, Oral Suspension, Heartburn and Indigestion Liquid
Brunel Healthcare Heartburn and Indigestion Liquid
Superdrug Acid Indigestion and Heartburn Relief Liquid
Heartburn and Indigestion Relief
SETLERS Heartburn and Indigestion Liquid
Coalgicarb Suspension
Lloydspharmacy Heartburn and Indigestion Liquid
Raft-Eze Liquid
Boots Heartburn Relief Aniseed Flavour
Co-op Heartburn and Indigestion Liquid
Entrocalm Heartburn and Indigestion Relief
Morrisons Heartburn and Indigestion Liquid
Peptac Liquid (Ivax Pharmaceuticals UK)
Asda Heartburn and Indigestion Liquid
Numark Heartburn and Indigestion Liquid
Wilkinson Heartburn and Indigestion Liquid
Sainsbury's Heartburn and Indigestion Liquid
2. Qualitative And Quantitative Composition
Each 5 ml contains:
Sodium Bicarbonate BP | 133.5 mg |
Sodium Alginate BP | 250 mg |
Calcium Carbonate BP | 80 mg |
3. Pharmaceutical Form
Aniseed Flavoured Pink Suspension
4. Clinical Particulars
4.1 Therapeutic Indications
Acidex Compound Alginate Oral Suspension Heartburn and Indigestion Liquid alleviates the painful conditions resulting from the reflux of gastric acid and bile into the oesophagus by suppressing the reflux itself. It is indicated in heartburn, including heartburn of pregnancy, dyspepsia associated with gastric reflux, hiatus hernia, reflux oesophagitis, regurgitation and all cases of epigastric and retrosternal distress where the underlying cause is gastric reflux.
4.2 Posology And Method Of Administration
For oral use
Adults and children over 12 years: | Two to four 5 ml spoonfuls. |
Children 6 - 12 years: | One to two 5 ml spoonfuls |
Not recommended in children under six years of age.
Doses should be taken after meals and at bedtime.
4.3 Contraindications
There are no specific contraindications.
4.4 Special Warnings And Precautions For Use
1. Each 10 ml dose of Acidex Compound Alginate Oral Suspension Heartburn and Indigestion Liquid contains about 6 mmoles of sodium and therefore care should be exercised in patients on a sodium restricted diet.
2. Acidex Compound Alginate Oral Suspension Heartburn and Indigestion Liquid should not be taken within 1 to 2 hours of taking other medicines by mouth, or for more than 2 weeks if symptoms persist.
3. Acidex Compound Alginate Oral Suspension Heartburn and Indigestion Liquid should not be used by patients allergic to any of its constituents.
4. Parahydroxybenzoates (E214 and E216): may cause allergic reactions (possibly delayed).
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
1. Antacids may interact with other drugs as they alter the gastric pH which may affect dissolution, solubility or ionization of the other drug. Antacids reduce the absorption of certain drugs from the following groups: ACE Inhibitors, Analgesics, Antibacterials, Antiepileptics, Antifungals, Antimalarials, Antipsychotics, Bisphosphonates, Penicillamine.
2. Antacids may increase the pH of the urine and affect the rate of drug elimination. Excretion of basic drugs is decreased whereas acidic drugs are eliminated more rapidly.
3. Due to effects at the renal level sodium bicarbonate may reduce plasma lithium levels and increase plasma quinidine levels.
4.6 Pregnancy And Lactation
Acidex Compound Alginate Oral Suspension Heartburn and Indigestion Liquid is indicated for heartburn of pregnancy and may be used during lactation.
For Acidex Compound Alginate Oral Suspension Heartburn and Indigestion Liquid no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. To date, no other relevant epidemiological data are available.
Caution should be exercised when prescribing to pregnant women.
4.7 Effects On Ability To Drive And Use Machines
There are no effects on ability to drive or operate machinery.
4.8 Undesirable Effects
Constipation, flatulence, stomach cramps or belching may occasionally occur.
4.9 Overdose
As Acidex Compound Alginate Oral Suspension Heartburn and Indigestion Liquid's mode of action is physical, overdosage in terms of the alginate content is virtually no hazard. The only consequence is abdominal distension which is best treated conservatively. The relatively low concentrations of sodium and calcium carbonate in Acidex Compound Alginate Oral Suspension Heartburn and Indigestion Liquid would also make serious consequences from overdosage very unlikely.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
When taken after a meal Sodium Alginate forms a rigid raft of alginic acid in the stomach reducing gastric reflux. This raft formed is maintained in the stomach for two hours. Sodium bicarbonate reacts with gastric acid to produce carbon dioxide which is retained in the gel and allows the raft to rise to the surface of the gastric contents. Calcium ions from calcium carbonate link the alginic acid molecules and strengthen the raft.
5.2 Pharmacokinetic Properties
Alginic acid is not absorbed into the systemic circulation.
5.3 Preclinical Safety Data
There is no Preclinical Safety Data.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Carbomer (Carbopol 974P)
Sodium Hydroxide
Saccharin Sodium
Ethyl parahydroxybenzoate (E214)
Propyl parahydroxybenzoate (E216)
Butyl parahydroxybenzoate
Isopropyl Alcohol
Erythrosine Colour (E127)
Aniseed Oil
Purified Water
6.2 Incompatibilities
None known.
6.3 Shelf Life
24 months - amber glass bottles
18 months - HDPE bottles
15 months – PET bottles
6.4 Special Precautions For Storage
Do not store above 25ºC. Do not refrigerate.
6.5 Nature And Contents Of Container
Pharmaceutical Grade III amber glass bottles with pilfer proof caps.
High density polyethylene bottles with tamper evident screw caps.
PET bottle with tamper evident screw caps.
Pack sizes: 50ml, 100ml, 150ml, 200ml, 250ml, 300ml and 500ml.
50ml (PET)
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
7. Marketing Authorisation Holder
Pinewood Laboratories Limited,
Ballymacarbry,
Clonmel,
Co. Tipperary.
8. Marketing Authorisation Number(S)
PL 4917/0021
9. Date Of First Authorisation/Renewal Of The Authorisation
25/03/1998
10. Date Of Revision Of The Text
19/04/2011
oxaliplatin
Generic Name: oxaliplatin (ox AL i PLA tin)
Brand Names: Eloxatin
What is oxaliplatin?
Oxaliplatin is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body.
Oxaliplatin is used together with other cancer medications to treat colon and rectal cancer.
Oxaliplatin may also be used for other purposes not listed in this medication guide.
What is the most important information I should know about oxaliplatin?
Do not use this medication without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. You should not receive this medication if you are allergic to oxaliplatin or similar medications such as carboplatin (Paraplatin) or cisplatin (Platinol).
Before receiving oxaliplatin, tell your doctor if you are allergic to any drugs, or if you have liver disease, asthma, or a nerve problem.
Receiving oxaliplatin can make you more sensitive to cold. This includes exposure to cold temperature and coming into contact with cold objects. To prevent discomfort avoid breathing in cold air, cover your skin in cold weather, wear gloves when handling cold objects, avoid air conditioning, and do not use ice or drink cold beverages.
Do not eat ice chips to ease mouth sores or nausea because you will be more sensitive to cold. Talk to your doctor about other ways to treat nausea or mouth sores.
Call your doctor if you have a serious side effect such as numbness or tingling, problems with speech or swallowing, chest tightness, fever with diarrhea or vomiting, increased thirst, decreased urination, easy bruising or bleeding, weakness, or mouth sores.
Oxaliplatin can lower blood cells that help your body fight infections. This can make it easier for you to bleed or get sick. Avoid being around others who are ill. Your blood will need to be tested on a regular basis. Your kidney and liver function may also need to be tested. Do not miss any scheduled appointments.
What should I discuss with my healthcare provider before receiving oxaliplatin?
You should not receive this medication if you are allergic to oxaliplatin or similar medications such as carboplatin (Paraplatin) or cisplatin (Platinol).
If you have any of these other conditions, you may need a dose adjustment or special tests to safely receive oxaliplatin:
liver disease;
asthma or other breathing disorder; or
a nerve problem.
FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not receive oxaliplatin without telling your doctor if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. It is not known whether oxaliplatin passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.
How is oxaliplatin given?
Oxaliplatin is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. The medicine must be given slowly through an IV infusion, and can take up at least 2 hours to complete.
Oxaliplatin is usually given as part of a 2-day treatment every 2 weeks. Follow your doctor's instructions.
Receiving oxaliplatin can make you more sensitive to cold. This includes exposure to cold temperature and coming into contact with cold objects. To prevent discomfort, follow these steps:
do not inhale deeply when you are exposed to cold air;
cover your skin, head, and face when you are outside in cold temperatures;
wear gloves when handling cold objects or refrigerated foods;
do not run an air conditioner at very cool temperature in your home or car (even during hot weather);
do not drink cold drinks or use ice cubes in drinks;
do not put ice packs on your body.
Chemotherapy often causes nausea or mouth sores. Do not eat ice chips to ease these discomforts because you will be more sensitive to cold. Talk to your doctor about other ways to treat nausea or mouth sores. You may be given other medications to prevent nausea or vomiting while you are receiving oxaliplatin.
Oxaliplatin can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your kidney and liver function may also need to be tested. Do not miss any scheduled appointments.
What happens if I miss a dose?
Contact your doctor if you miss an appointment for your oxaliplatin injection.
What happens if I overdose?
Seek emergency medical attention if you think you have received too much of this medicine.
Overdose symptoms may include easy bruising or bleeding, unusual weakness, severe vomiting or diarrhea, numbness or tingling, flu symptoms, wheezing, trouble breathing, chest pain, slow heart rate, weak or shallow breathing (breathing may stop).
What should I avoid while using oxaliplatin?
Avoid cold temperatures and cold objects, including ice, cold drinks, and skin exposure to cold temperatures.
Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.
Oxaliplatin can cause side effects that may impair your vision. Be careful if you drive or do anything that requires you to be able to see clearly.
Oxaliplatin side effects
Some people receiving a oxaliplatin injection have had a reaction to the infusion within minutes after the medicine is injected into the vein. Tell your caregiver right away if you feel short of breath, confused, sweaty, itchy, or have diarrhea, chest pain, warmth or redness in your face, or feel like you might pass out. Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:
numbness or tingly feeling in your hands, feet, throat, and around your mouth;
numbness or burning pain that interferes with daily activities;
increased sensitivity to cold temperatures and cold objects;
jaw or chest tightness, eye pain, strange feeling in your tongue, problems with speech or swallowing;
fever, diarrhea, vomiting, chills, body aches, flu symptoms, sudden cough;
increased thirst, dry mouth, urinating less than usual;
decreased vision;;
easy bruising or bleeding, unusual weakness; or
white patches or sores inside your mouth or on your lips.
Less serious side effects may include:
nausea, stomach pain, loss of appetite;
constipation;
tired feeling;
hair loss;
decreased taste sensation;
muscle pain;
headache;
sleep problems (insomnia);
swelling; or
back pain.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Oxaliplatin Dosing Information
Usual Adult Dose for Colorectal Cancer:
Day 1:
Oxaliplatin 85 mg/m2 and leucovorin 200 mg/m2 intravenously over 120 minutes, followed by
fluorouracil 400 mg/m2 over 2 to 4 minutes, followed by
fluorouracil 600 mg/m2 as a 22 hour infusion.
Day 2:
Leucovorin 200 mg/m2 intravenously over 120 minutes, followed by
fluorouracil 400 mg/m2 over 2 to 4 minutes, followed by
fluorouracil 600 mg/m2 as a 22 hour infusion.
The cycle is repeated every 2 weeks.
What other drugs will affect oxaliplatin?
Before you receive oxaliplatin, tell your doctor if you also take a blood thinner such as warfarin (Coumadin).
There may be other drugs that can interact with oxaliplatin. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.
More oxaliplatin resources
- Oxaliplatin Side Effects (in more detail)
- Oxaliplatin Dosage
- Oxaliplatin Use in Pregnancy & Breastfeeding
- Oxaliplatin Drug Interactions
- Oxaliplatin Support Group
- 1 Review for Oxaliplatin - Add your own review/rating
- oxaliplatin Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information
- Oxaliplatin Prescribing Information (FDA)
- Oxaliplatin Professional Patient Advice (Wolters Kluwer)
- Oxaliplatin Monograph (AHFS DI)
- Oxaliplatin MedFacts Consumer Leaflet (Wolters Kluwer)
- Eloxatin Prescribing Information (FDA)
- Eloxatin Consumer Overview
Compare oxaliplatin with other medications
- Colorectal Cancer
Where can I get more information?
- Your doctor or pharmacist can provide more information about oxaliplatin.
See also: oxaliplatin side effects (in more detail)
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