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WHAT IS ZORETANIN?
Zoretanin ( isotretinoin 20mg) is used to treat severe, disfiguring nodular acne. It should be used only after other acne medicines have been tried and have failed to help the acne. Zoretanin ( isotretinoin 20mg) may also be used to treat other skin diseases as determined by your doctor.
Zoretanin ( isotretinoin 20mg) must not be used to treat women who are able to bear children unless other forms of treatment have been tried first and have failed. Zoretanin ( isotretinoin 20mg) must not be taken during pregnancy because it causes birth defects in humans. If you are able to bear children, it is very important that you read, understand, and follow the pregnancy warnings for Zoretanin. ( isotretinoin 20mg)
( isotretinoin 20mg) is used in certain patients with the following medical conditions:
- Folliculitis, gram-negative (bacterial infection of the skin on the face beginning near the nose).
- Hidradenitis suppurativa (sweat gland problem).
- Rosacea (red skin disorder of the face, usually of the nose and cheeks).
- Thickened or patchy skin disorders, such as keratosis follicularis, palmoplantar keratoderma, lamellar ichthyosis, or pityriasis rubra pilaris.
ZORETANIN ( isotretinoin 20mg) INDICATIONS
Severe Recalcitrant Nodular Acne
Storage
Store at controlled room temperature (59° to 86°F, 15° to 30°C). Protect from light.
ZORETANIN ( isotretinoin 20mg) INTERACTIONS
- Vitamin A: Because of the relationship of Zoretanin ( isotretinoin 20mg) (Zoretanin) to vitamin A, patients should be advised against taking vitamin supplements containing vitamin A to avoid additive toxic effects.
- Tetracyclines: Concomitant treatment with Zoretanin ( isotretinoin 20mg) (Zoretanin) and tetracyclines should be avoided because Zoretanin ( isotretinoin 20mg) (Zoretanin) use has been associated with a number of cases of pseudotumor cerebri (benign intracranial hypertension), some of which involved concomitant use of tetracyclines.
- Micro-dosed Progesterone Preparations: Micro-dosed progesterone preparations (“minipills” that do not contain an estrogen) may be an inadequate method of contraception during Zoretanin ( isotretinoin 20mg) (Zoretanin) therapy. Although other hormonal contraceptives are highly effective, there have been reports of pregnancy from female patients who have used combined oral contraceptives, as well as transdermal patch/injectable/implantable/vaginal ring hormonal birth control products. These reports are more frequent for female patients who use only a single method of contraception. It is not known if hormonal contraceptives differ in their effectiveness when used with Zoretanin ( isotretinoin 20mg) (Zoretanin). Therefore, it is critically important for female patients of childbearing potential to select and commit to use 2 forms of effective contraception simultaneously, at least 1 of which must be a primary form.
- Norethindrone/ethinyl estradiol: In a study of 31 premenopausal female patients with severe recalcitrant nodular acne receiving OrthoNovum® 7/7/7 Tablets as an oral contraceptive agent, Zoretanin ( isotretinoin 20mg) (Zoretanin) at the recommended dose of 1 mg/kg/day, did not induce clinically relevant changes in the pharmacokinetics of ethinyl estradiol and norethindrone and in the serum levels of progesterone, follicle-stimulating hormone (FSH) and luteinizing hormone (LH). Prescribers are advised to consult the package insert of medication administered concomitantly with hormonal contraceptives, since some medications may decrease the effectiveness of these birth control products.
- St. John’s Wort: Zoretanin ( isotretinoin 20mg) (Zoretanin) use is associated with depression in some patients. Patients should be prospectively cautioned not to self-medicate with the herbal supplement St. John’s Wort because a possible interaction has been suggested with hormonal contraceptives based on reports of breakthrough bleeding on oral contraceptives shortly after starting St. John’s Wort. Pregnancies have been reported by users of combined hormonal contraceptives who also used some form of St. John’s Wort.
- Phenytoin: Zoretanin ( isotretinoin 20mg) (Zoretanin) has not been shown to alter the pharmacokinetics of phenytoin in a study in seven healthy volunteers. These results are consistent with the in vitro finding that neither Zoretanin ( isotretinoin 20mg) nor its metabolites induce or inhibit the activity of the CYP 2C9 human hepatic P450 enzyme. Phenytoin is known to cause osteomalacia. No formal clinical studies have been conducted to assess if there is an interactive effect on bone loss between phenytoin and Zoretanin (Zoretanin). Therefore, caution should be exercised when using these drugs together.
- Systemic Corticosteroids: Systemic corticosteroids are known to cause osteoporosis. No formal clinical studies have been conducted to assess if there is an interactive effect on bone loss between systemic corticosteroids and Zoretanin ( isotretinoin 20mg) (Zoretanin). Therefore, caution should be exercised when using these drugs together.
ZORETANIN SIDE EFFECTS
The following adverse reactions with Zoretanin ( isotretinoin 20mg) or other Zoretanin ( isotretinoin 20mg) products are described in more detail in other sections of the labeling:
- Embryofetal Toxicity
- Psychiatric Disorders
- Pseudotumor Cerebri
- Serious Skin Reactions
- Pancreatitis
- Lipid Abnormalities
- Hearing Impairment
- Inflammatory Bowel Disease
- Ocular Abnormalities
- Hypersensitivity
ZORETANIN ( isotretinoin 20mg) CONTRAINDICATIONS
What is the most important information I should know about Zoretanin ( isotretinoin 20mg) ?
Hypersensitivity to Zoretanin ( isotretinoin 20mg) or to any of the excipients of Zoretanin ( isotretinoin 20mg) . Hepatic or renal insufficiency; hypervitaminosis A; patients with excessively elevated blood lipid values.
Use in pregnancy: Pregnancy Category X: Zoretanin is highly teratogenic. It is, therefore, contraindicated not only in women who are pregnant or who may become pregnant while undergoing treatment but also in all women of childbearing potential. There is an extremely high risk that a deformed infant will result if pregnancy occurs while taking Zoretanin ( isotretinoin 20mg) in any amount even for short periods. Potentially all exposed foetuses can be affected.
Zoretanin ( isotretinoin 20mg) is contraindicated in women of childbearing potential unless the female patient meets all of the following conditions: Severe disfiguring cystic acne resistant to standard therapies; reliability in understanding and carrying out instructions; compliance with the mandatory contraceptive measures; informed by the physician of the hazards of becoming pregnant during and 1 month after treatment with Zoretanin ( isotretinoin 20mg) and warned of the possibility of contraceptive failure; confirms that patient has understood the warnings; negative pregnancy test within 2 weeks prior to beginning therapy, monthly repetition of pregnancy testing is recommended; use effective contraception without any interruption for at least 1 month before beginning Zoretanin ( isotretinoin 20mg) therapy, during therapy and for 1 month following discontinuation of therapy. At least 1 and preferably 2 complementary forms of contraception including a barrier method should be used. Microdosed progesterone preparations (minipills) may be an inadequate method of contraception during Zoretanin ( isotretinoin 20mg) therapy. If the patient starts Zoretanin ( isotretinoin 20mg) therapy only on the 2nd or 3rd day of the next menstrual period; in the event of relapse treatments, patient must also use the same uninterrupted and effective contraceptive measures 1 month prior to, during and for 1 month after Zoretanin ( isotretinoin 20mg) therapy; must fully understand the precautions and confirm patient understanding and willingness to comply with reliable contraceptive measures as explained.
Even female patients, who normally do not employ contraception because of a history of infertility, should be advised to do so while taking Zoretanin ( isotretinoin 20mg) , following the previously stated guidelines.
Should pregnancy occur inspite of these precautions during treatment with Zoretanin ( isotretinoin 20mg) or in the month following, there is a great risk of very severe malformation of the foetus (involving in particular the central nervous system, heart and large blood vessels). If pregnancy does occur, the physician and patient should discuss the advisability of continuing the pregnancy.
Major human foetal abnormalities related to Zoretanin ( isotretinoin 20mg) administration have been documented, including hydrocephalus, microcephalus, abnormalities of the external ear (micropinna, small or absent external auditory canals), microphthalmia, cardiovascular abnormalities, facial dysmorphia, thymus gland abnormalities, parathyroid hormone deficiency and cerebellar malformation. There is also an increased risk of spontaneous abortion.
Zoretanin ( isotretinoin 20mg) is highly teratogenic and must not be given to women who are pregnant. Zoretanin ( isotretinoin 20mg) crosses the placental barrier in amounts that lead to congenital deformities. There is an extremely high risk that a deformed infant will result if pregnancy occurs while taking Zoretanin ( isotretinoin 20mg) in any amount even for short periods. Potentially all exposed foetuses can be affected.
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