How do you administer this medicine?
Dosage of Thincal in details
The recommended dose of Thincal is one 120-mg capsule three times a day with each main meal containing fat (during or up to 1 hour after the meal).
The patient should be on a nutritionally balanced, reduced-calorie diet that contains approximately 30% of calories from fat. The daily intake of fat, carbohydrate, and protein should be distributed over three main meals. If a meal is occasionally missed or contains no fat, the dose of Thincal can be omitted.
Because Thincal has been shown to reduce the absorption of some fat-soluble vitamins and betacarotene, patients should be counseled to take a multivitamin containing fat-soluble vitamins to ensure adequate nutrition. The vitamin supplement should be taken at least 2 hours before or after the administration of Thincal, such as at bedtime.
For patients receiving both Thincal and cyclosporine therapy, administer cyclosporine 3 hours after Thincal.
For patients receiving both Thincal and levothyroxine therapy, administer levothyroxine and Thincal at least 4 hours apart. Patients treated concomitantly with Thincal and levothyroxine should be monitored for changes in thyroid function.
Doses above 120 mg three times a day have not been shown to provide additional benefit.
Based on fecal fat measurements, the effect of Thincal is seen as soon as 24 to 48 hours after dosing. Upon discontinuation of therapy, fecal fat content usually returns to pretreatment levels within 48 to 72 hours.
Dosage Forms And Strengths
Thincal 120 mg turquoise capsules imprinted with ROCHE and Thincal 120 in black ink.
Thincal is a turquoise, hard-gelatin capsule containing pellets of powder.
Thincal 120 mg Capsules: Turquoise, two-piece, No. 1 opaque hard-gelatin capsule imprinted with ROCHE and Thincal 120 in black ink - bottle of 90 (NDC 0004-0257-52).
Storage And Handling
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Keep bottle tightly closed.
Thincal should not be used after the given expiration date.
Distributed by: Genentech USA, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990. Revised: Aug 2016
What other drugs will affect Thincal?
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Thincal, especially:
insulin or oral diabetes medicine;
seizure medication (especially if your seizures get worse while taking Thincal;
a vitamin or mineral supplement that contains beta carotene or vitamin E; or
warfarin (Coumadin, Jantoven).
This list is not complete. Other drugs may interact with Thincal, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Data from a Thincal and cyclosporine drug interaction study indicate a reduction in cyclosporine plasma levels when Thincal was coadministered with cyclosporine. Thincal and cyclosporine should not be simultaneously coadministered. Cyclosporine should be administered 3 hours after the administration of Thincal.
Fat-soluble Vitamin Supplements And Analogues
Data from a pharmacokinetic interaction study showed that the absorption of beta-carotene supplement is reduced when concomitantly administered with Thincal. Thincal inhibited absorption of a vitamin E acetate supplement. The effect of Thincal on the absorption of supplemental vitamin D, vitamin A, and nutritionally-derived vitamin K is not known at this time.
Hypothyroidism has been reported in patients treated concomitantly with Thincal and levothyroxine postmarketing. Patients treated concomitantly with Thincal and levothyroxine should be monitored for changes in thyroid function. Administer levothyroxine and Thincal at least 4 hours apart.
Anticoagulants Including Warfarin
Vitamin K absorption may be decreased with Thincal. Reports of decreased prothrombin, increased INR and unbalanced anticoagulant treatment resulting in change of hemostatic parameters have been reported in patients treated concomitantly with Thincal and anticoagulants. Patients on chronic stable doses of warfarin or other anticoagulants who are prescribed Thincal should be monitored closely for changes in coagulation parameters.
A pharmacokinetic study, where amiodarone was orally administered during Thincal treatment, demonstrated a reduction in exposure to amiodarone and its metabolite, desethylamiodarone. A reduced therapeutic effect of amiodarone is possible. The effect of commencing Thincal treatment in patients on stable amiodarone therapy has not been studied.
Convulsions have been reported in patients treated concomitantly with Thincal and antiepileptic drugs. Patients should be monitored for possible changes in the frequency and/or severity of convulsions.
Loss of virological control has been reported in HIV-infected patients taking Thincal concomitantly with antiretroviral drugs such as atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, and with the combinations lopinavir/ritonavir and emtricitabine/efavirenz/tenofovir disoproxil fumarate. The exact mechanism for this is unclear, but may include a drug-drug interaction that inhibits systemic absorption of the antiretroviral drug. HIV RNA levels should be frequently monitored in patients who take Thincal while being treated for HIV infection. If there is a confirmed increase in HIV viral load, Thincal should be discontinued.
Drug Abuse And Dependence
As with any weight-loss agent, the potential exists for abuse of Thincal in inappropriate patient populations (e.g., patients with anorexia nervosa or bulimia). See INDICATIONS AND USAGE for recommended prescribing guidelines.
- DailyMed. "ORLISTAT: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- FDA/SPL Indexing Data. "95M8R751W8: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
- MeSH. "Anti-Obesity Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
ReviewsThe results of a survey conducted on ndrugs.com for Thincal are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Thincal. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
9 consumers reported frequency of useHow frequently do I need to take Thincal?
It was reported by ndrugs.com website users that Thincal should ideally be taken Once in a day as the most common frequency of the Thincal. You should you adhere strictly to the instructions and guidelines provided by your doctor on how frequently this Thincal should be taken. Get another patient's view on how frequent the capsule should be used by clicking here.
|Once in a day||4||44.4%|
|Twice in a day||3||33.3%|
|3 times in a day||2||22.2%|
13 consumers reported dosesWhat doses of Thincal drug you have used?
The drug can be in various doses. Most anti-diabetic, anti-hypertensive drugs, pain killers, or antibiotics are in different low and high doses and prescribed by the doctors depending on the severity and demand of the condition suffered by the patient. In our reports, ndrugs.com website users used these doses of Thincal drug in following percentages. Very few drugs come in a fixed dose or a single dose. Common conditions, like fever, have almost the same doses, e.g., [acetaminophen, 500mg] of drug used by the patient, even though it is available in various doses.
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Information checked by Dr. Sachin Kumar, MD Pharmacology