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Minoxidil 2.5 Mg Tabs 100 By Par Pharma

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Minoxidil 2.5 Mg Tabs 100 By Par Pharma

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Minoxidil 2.5 Mg Tabs 100 By Par Pharma This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXD1706621/RXB10034248
Size : 100
Selling UoM : EA
NDC: 49884-0256-01
UPC Barcode : 349884256012
Supplier: 0050000428 PAR PHARM INC
Supplier Material : 025601
Generic Code : 000300 MINOXIDIL ORAL TABLET 2.5 MG
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : GRX Generic RX

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Product Description.:

MINOXIDIL 2 1/2, par 256
tablet , white , scored , round round

Minoxidil tablets contain the powerful antihypertensive agent, minoxidil, which may produce serious adverse effects. It can cause pericardial effusion, occasionally progressing to tamponade, and angina pectoris may be exacerbated. Minoxidil should be reserved for hypertensive patients who do not respond adequately to maximum therapeutic doses of a diuretic and two other antihypertensive agents.

In experimental animals, minoxidil caused several kinds of myocardial lesions as well as other adverse cardiac effects (see Cardiac Lesions in Animals).

Minoxidil must be administered under close supervision, usually concomitantly with therapeutic doses of a beta-adrenergic blocking agent to prevent tachycardia and increased myocardial workload. It must also usually be given with a diuretic, frequently one acting in the ascending limb of the loop of Henle, to prevent serious fluid accumulation. Patients with malignant hypertension and those already receiving guanethidine (see WARNINGS) should be hospitalized when minoxidil is first administered so that they can be monitored to avoid too rapid, or large orthostatic, decreases in blood pressure.

DRUG DESCRIPTION

Minoxidil tablets contain minoxidil, an antihypertensive peripheral vasodilator. Minoxidil occurs as a white to off-white, crystalline powder, soluble in alcohol and propylene glycol sparingly soluble in methanol slightly soluble in water practically insoluble in chloroform, acetone and ethyl acetate.

Minoxidil tablets for oral administration contain either 2.5 mg or 10 mg of minoxidil.

Minoxidil Tablets USP 2.5 mg and 10 mg contain the following inactive ingredients: anhydrous lactose, docusate sodium, magnesium stearate, microcrystalline cellulose, sodium benzoate and sodium starch glycolate.

INDICATIONS

Because of the potential for serious adverse effects, minoxidil tablets are indicated only in the treatment of hypertension that is symptomatic or associated with target organ damage and is not manageable with maximum therapeutic doses of a diuretic plus two other antihypertensive drugs. At the present time use in milder degrees of hypertension is not recommended because the benefit-risk relationship in such patients has not been defined. Minoxidil reduced supine diastolic blood pressure by 20 mm Hg or to 90 mm Hg or less in approximately 75% of patients, most of whom had hypertension that could not be controlled by other drugs.
DOSAGE AND ADMINISTRATION
Patients over 12 years of age

The recommended initial dosage of minoxidil tablets is 5 mg of minoxidil given as a single daily dose. Daily dosage can be increased to 10, 20 and then to 40 mg in single or divided doses if required for optimum blood pressure control. The effective dosage range is usually 10 to 40 mg per day. The maximum recommended dosage is 100 mg per day.
Patients under 12 years of age

The initial dosage is 0.2 mg/kg minoxidil as a single daily dose. The dosage may be increased in 50 to 100% increments until optimum blood pressure control is achieved. The effective dosage range is usually 0.25 to 1 mg/kg/day. The maximum recommended dosage is 50 mg daily (see Pediatric Use under PRECAUTIONS). Dose frequency: The magnitude of within-day fluctuation of arterial pressure during therapy with minoxidil is directly proportional to the extent of pressure reduction. If supine diastolic pressure has been reduced less than 30 mm Hg, the drug need be administered only once a day if supine diastolic pressure has been reduced more than 30 mm Hg, the daily dosage should be divided into two equal parts.

SIDE EFFECTS

1. Salt and Water Retention (see WARNINGS: Concomitant Use of an Adequate Diuretic is Required)-Temporary edema developed in 7% of patients who were not edematous at the start of therapy.
2. Pericarditis, Pericardial Effusion, and Tamponade (see WARNINGS).
3. Dermatologic-Hypertrichosis-Elongation, thickening, and enhanced pigmentation of fine body hair are seen in about 80% of patients taking minoxidil tablets. This develops within 3 to 6 weeks after starting therapy. It is usually first noticed on the temples, between the eyebrows, between the hairline and the eyebrows, or in the side-burn area of the upper lateral cheek, later extending to the back, arms, legs, and scalp. Upon discontinuation of minoxidil, new hair growth stops, but 1 to 6 months may be required for restoration to pretreatment appearance. No endocrine abnormalities have been found to explain the abnormal hair growth thus, it is hypertrichosis without virilism. Hair growth is especially disturbing to children and women and such patients should be thoroughly informed about this effect before therapy with minoxidil is begun. Allergic-Rashes have been reported, including rare reports of bullous eruptions, and Stevens-Johnson Syndrome.
4. Hematolo