Midothal

Midothal50mg

Type:Capsule

Generic Name:Thalidomide

Manufacturer:Incepta Pharmaceuticals Ltd.

Price:30.00

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Indication

Multiple myeloma, Erythema nodosum leprosum

Administration

Should be taken on an empty stomach. Take on an empty stomach at least 1 hr after a meal, w/ a full glass of water.

Adult Dose

Oral Erythema nodosum leprosum (Type 2) Adult: 100-300 mg once daily at bedtime, reduced gradually by 50 mg every 2-4 wk once a satisfactory reponse is achieved. Not for monotherapy if moderate or severe neuritis present. Max: 400 mg/day. Patients < 50 kg: Initially, 100 mg daily. Multiple myeloma Adult: Initial dose of 200 mg once daily, increased by 100 mg at wkly intervals according to patient tolerance. Max: 800 mg daily.

Contraindication

Hypersensitivity. Pregnancy and lactation.

Mode of Action

Thalidomide is a synthetic glutamic acid derivative immunomodulator with anti-inflammatory, antiangiogenetic, sedative and hypnotic activity.

Precaution

All females of childbearing potential must use 2 reliable forms of contraception simultaneously 4 wk before starting therapy, during and 4 wk after therapy is discontinued. Therapy to be stopped immediately if pregnancy occurs. Male: Use of barrier methods of contraception if partner is of child-bearing potential. Do not donate blood or sperm during therapy. Patient should not drive or operate machinery. Discontinue therapy if any skin rash develops. Do not resume therapy if the rash is exfoliative, purpuric, or bullous, or if Stevens-Johnson syndrome or toxic epidermal necrolysis suspected. Lactation: not known if excreted in breast milk, not recommended

Side Effect

>10% Somnolence (37%),Rash (21%),Edema (57%),Hypotension (16%),Leukopenia (17-35%),Neutropenia (31%),Increased bilirubin (14%),Myalgia (17%),Arthralgia (13%),Hematuria (11%),Thrombosis/embolism (23%),Headache (12%),Dyspnea (42%) 1-10% Asthenia (8%),General pain (8%),Impotence (8%),Malaise (8%),Pruritus (8%),Xerostomia (8%),Flatulence (8%),Tooth pain (4%),Impotence (3-8%),Vertigo (8%),Constipation (4%),Diarrhea (4%),Neck rigidity (4%) Frequency Not Defined Photosensitivity,Bradycardia,Hypo/hypertension,Peripheral neuropathy,Neutropenia Potentially Fatal: Stevens-Johnson syndrome, toxic epidermal necrolysis and blood dyscrasias.

Interaction

Thalidomide enhances sedative activity of barbiturates, alcohol, chlorpromazine and reserpine. Avoid use of other drugs that have the potential to cause peripheral neuropathy. Increased risk of thromboembolic events with darbepoetin-alfa and doxorubicin. Potentially Fatal: Increased risk of bone marrow supression with peg interferon alfa.

Alternative brand of Midothal