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PRODUCT DETAILS

Brand Name : Thalix
Composition : Thalidomide
Strength availability : 100mg
Manufactured by : Fresenius Kabi India
Pack : 10 capsules in a strip
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Thalidomide is a generic of brand name of Thalix 50mg.
Thalix 100mg appeared as a hopeful alternative to barbiturates which were then needed as sedatives, because it didn’t seem to be toxic nor have any side effects. The overdose would only cause deep sleep, as hostile to barbiturates which could cause death if taken in more quantity.It has been renewing and indicated for several immunological and inflammatory disorders.
Thalix 100mg displays immunosuppressive and anti-angiogenic activity. It prevents release of tumor necrosis factor-alpha from monocytes and modulates another cytokine action.

INDICATION

Thalix 100mg is indicated for treatment of skin lesions associated with leprosy.
Thalix 100mg is indicated in various cancer conditions such as: multiple myeloma, renal cell carcinoma, glioblastoma multiforme and Waldenström macroglobulinemia. As well as treatment of graft vs. host disease (GVHD) after bone marrow transplant.

DOSAGE

The dosage recommendation of following condition as follows :
Multiple Myeloma :
The prescribed dose is 200mg PO qHS in 28-day cycles
Take 40 mg of dexamethasone on days 1-4,9-12,17-20 of 28 days.
Erythema Nodosum leprosum :
The initial prescribed dose is 100-300 mg PO qHS.
If more severe reaction then may initiate at 400mg. continue until active symptoms subsided, at least 2 weeks then titrate down by 50 mg increment q 2-4 weeks.

MECHANISM

Extra, thalidomide is known to have different effects on the immune system (immunomodulatory agent), which may provide to its healing effect. Thalidomide may also change the production and activity of cytokines (growth factors) contains in the growth and durability of certain cancer cells. There may be an effect on the genes which direct the cell's development and activity specifically those along with cytokines (growth factors), apoptosis (cell death), and metabolism.

ADME

Absorption:
Time to peak plasma concentration is 2.9 to 5.7 hours
Distribution:
plasma protein binding is 55% and 66% for the (+) R and (-) S enantiomers, respectively
Metabolism:
Metabolized hepatically by enzymes of the cytochrome P450 enzyme system.
Elimination:
excreted in the urine as unchanged drug is less than 0.7% of the dose.
Half-life of thalidomide is 5 to 7 hours.

PRECAUTION

For both men and women use contraceptives, and do not conceive a child (get pregnant) while taking Thalix 100mg. serious, life-threatening birth defects may have reported with even one 50 mg dose. Methods of contraception has two types, such as latex condoms and spermicides, are required.
For women of childbearing potential should use contraception 4 weeks before you can start Thalix 100mg. The manufacturer needed you to take a pregnancy test every month before you initiate a new prescription of thalidomide. This is to confirm that you or your significant other is not pregnant. Consult with your doctor when you may safely become pregnant or conceive a child after treatment.
Prior initiating Thalix 100mg treatment, make sure to inform doctor about any other medications you are taking (containing prescription, over-the-counter, vitamins, herbal remedies, etc.). Avoid taking aspirin, or products including aspirin until the doctor especially permits this.
Avoid taking regimens that may cause drowsiness without first consulting your health care provider. Also avoid alcohol.
Do not breast feed while taking this medication.

DRUG INTERACTION

Combination of Thalix 100mg with opioids, antihistamines, antipsychotics, anti-anxiety agents, other CNS depressants may lead to additive sedative effect.
Concomitant use of Thalix 100mg with cardiovascular medication will cause an additive bradycardic effect and should be used with caution.
Interaction with bortezomib, amiodarone, cisplatin, docetaxel, paclitaxel, vincristine etc will cause peripheral neuropathy and should be used with caution.
Unknown condition when concomitant use of hormonal contraceptives further increases the risk of thromboembolism with Thalix

CONTRAINDICATION

Hypersentivity
Pregnancy - the drug cause risk to fetal

STORAGE

Store at 20℃ - 25℃.
Protect the drug from light

MISSED DOSE

Take the dose immediately before next dose duration. Next dose time reaches then left off the missed dose and continue regular schedule. Avoid taking double dose at same time. Please consult the doctor for further information.

SIDE EFFECTS

• Neutropenia
• Thrombocytopenia
• Increased HIV viral load
• Bradycardia
• Seizures
• Tumor Lysis
• Hypersensitivity
• Teratogenicity
• Venous and arterial thromboembolism
• Increased Mortality
• Drowsiness and somnolence
• Peripheral neuropathy
• Dizziness and orthostatic hypotension.

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