(Generic Isotretinoin) – Product Information
Tretiva capsule is used for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or more. The nodules may become suppurative or hemorrhagic. Due to the risk of significant adverse effects associated with its use, Generic Isotretinoin should be reserved for patients with severe nodular acne who are not responsive to conventional therapy, including systemic antibiotics.
In addition, Tretiva capsules should be used by only those female patients who are not pregnant, because Generic Accutane (Tretiva capsules) can cause severe birth defects.
Tretiva capsules are manufactured by Intas Pharmaceuticals Ltd. in the strengths of 5 mg, 10 mg, 20 mg, 30mg and 40 mg. We also have in stock Generic Accutane/ Roaccutane (Isotroin by Cipla) which is also used to treat the same indications.
Name of the Drug
We supply original Tretiva capsules manufactured by Intas Pharmaceuticals Ltd..
Manufacturer of Tretiva Capsules
Intas Pharmaceuticals Ltd.
Active Ingredient present in Tretiva Capsules
The active ingredient present in Tretiva capsules is Isotretinoin. Each soft gel Tretiva capsule contains 5 mg, 10 mg, 20 mg or 40 mg of the active ingredient Isotretinoin.
Uses of Generic Isotretinoin (Tretiva Capsules)
Generic Isotretinoin (Tretiva Capsules) is used to treat severe nodular acne. It is usually given after other types of acne medications or antibiotics have been tried without successful treatment of symptoms.
Generic Isotretinoin (Tretiva Capsules) – Dosage
Isotretinoin therapy should be started at a dose of 0.5 mg/kg daily. The therapeutic response to Isotretinoin and some of the adverse effects are dose-related and vary between patients. The recommended dosage range for Tretiva Capsules is 0.5 to 1 mg/kg/day given in two divided doses with or without meals for 15 to 20 weeks. To decrease the risk of esophageal irritation, patients should swallow Tretiva capsules with a full glass of liquid.
Your acne may seem to get worse at first, but should then begin to improve.
To be sure Tretiva capsules (Generic Isotretinoin) are not causing harmful effects, your blood may need to be tested often. Your liver function may also need to be tested. Visit your doctor regularly.
Tretiva Capsules Contraindications
Tretiva capsules are contraindicated in patients with a hypersensitivity to Isotretinoin or any inactive ingredient present in Tretiva capsules . Isotretinoin contraindicated for the treatment of prepubertal acne and is not recommended in patients less than 12 years of age due to a lack of data on efficacy and safety.
Generic Isotretinoin (Tretiva Capsules) is contraindicated in females who are or may become pregnant. If this medicine is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued and the patient should be apprised of the potential hazard to the fetus.
Store Tretiva Capsules at controlled room temperature (59°F to 86°F, 15°C to 30°C). Protect from light.
Warnings and Precautions
The warnings and precautions associated with Tretiva Capsules(Generic Isotretinoin) therapy are given below:
- Psychiatric Disorders
Accutane may cause depression, psychosis and, rarely, suicidal ideation, suicide attempts, suicide, and aggressive and/or violent behaviors.
- Pseudotumor Cerebri
Accutane use has been associated with a number of cases of pseudotumor cerebri (benign intracranial hypertension), some of which involved concomitant use of tetracyclines. Concomitant treatment with tetracyclines should therefore be avoided. Early signs and symptoms of pseudotumor cerebri include papilledema, headache, nausea and vomiting, and visual disturbances.
Acute pancreatitis has been reported in patients with either elevated or normal serum triglyceride levels. In rare instances, fatal hemorrhagic pancreatitis has been reported. Accutane should be stopped if hypertriglyceridemia cannot be controlled at an acceptable level or if symptoms of pancreatitis occur.
Elevations of serum triglycerides in excess of 800 mg/dL have been reported in patients treated with Accutane.
- Hearing Impairment
Impaired hearing has been reported in patients taking Accutane; in some cases, the hearing impairment has been reported to persist after therapy has been discontinued.
Clinical hepatitis considered to be possibly or probably related to Accutane therapy has been reported. Additionally, mild to moderate elevations of liver enzymes have been observed in approximately 15% of individuals treated during clinical trials, some of which normalized with dosage reduction or continued administration of the drug. If normalization does not readily occur or if hepatitis is suspected during treatment with Accutane, the drug should be discontinued.
- Inflammatory Bowel Disease
Accutane has been associated with inflammatory bowel disease (including regional ileitis) in patients without a prior history of intestinal disorders.
- Premature Epiphyseal Closure
There are spontaneous reports of premature epiphyseal closure in acne patients receiving recommended doses of Accutane.
- Vision Impairment
Visual problems should be carefully monitored. All Accutane patients experiencing visual difficulties should discontinue Accutane treatment and have an ophthalmological examination.
- Corneal Opacities
Corneal opacities have occurred in patient s receiving Accutane for acne and more frequently when higher drug dosages were used in patients with disorders of keratinization.
- Decreased Night Vision
Decreased night vision has been reported during Accutane therapy and in some instances the event has persisted after therapy was discontinued.
Generic Isotretinoin Overdose
In humans, Generic Isotretinoin overdosage has been associated with vomiting, facial flushing, cheilosis, abdominal pain, headache, dizziness, and ataxia. These symptoms quickly resolve without apparent residual effects.
Female patients of childbearing potential who have administered themselves an overdose of Isotretinoin capsules must be evaluated for pregnancy. Patients who are pregnant should receive counseling about the risks to the fetus.
Due to the fact that an overdose would be expected to result in higher levels of Isotretinoin in semen than found during a normal treatment course, male patients should use a condom, or avoid reproductive sexual activity with a female patient who is or might become pregnant, for 1 month after the overdose.
All patients with Isotretinoin overdose should not donate blood for at least 1 month.
Isotretinoin During Pregnancy
Isotretinoin has been classified by the US FDA as Pregnancy Category X.
Tretiva Capsules(Generic Isotretinoin) must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Accutane in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected.
Birth defects which have been documented following Isotretinoin exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands.
Do not use this medicine in case you are pregnant. Stop using this medication and inform your doctor immediately if you become pregnant during treatment.
It is not known whether Isotretinoin is excreted in human milk. Because of the potential for adverse effects, nursing mothers should not be administered Tretiva capsules.
Do not use this medication without telling your doctor if you are breast-feeding a baby.