midodrine hydrochloride

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Related to ProAmatine: Midodrine, Midodrine hydrochloride

midodrine hydrochloride

Amatine (CA), Apo-Midodrine (CA), Orvaten, ProAmatine

Pharmacologic class: Alpha1-adrenergic agonist

Therapeutic class: Antihypotensive, vasopressor

Pregnancy risk category C

FDA Box Warning

• Drug can markedly increase supine blood pressure, and should be used in patients whose lives are considerably impaired despite standard clinical care. Indication for its use in treating symptomatic orthostatic hypotension rests mainly on an increase in systolic pressure measured 1 minute after standing. Currently, drug's clinical benefits (mainly improved ability to perform activities of daily living) haven't been verified.

Action

Forms active metabolite, desglymidodrine, an alpha1-adrenergic agonist that activates alpha-adrenergic receptors in arteriolar and venous vasculature. This effect increases vascular resistance and ultimately raises blood pressure.

Availability

Tablets: 2.5 mg, 5 mg

Indications and dosages

Symptomatic orthostatic hypotension

Adults: 10 mg P.O. t.i.d. during daytime hours with patient in upright position. Give first dose when patient arises in morning, second dose at midday, and third dose in late afternoon.

Dosage adjustment

• Renal impairment

Contraindications

• Severe coronary artery disease or organic heart disease
• Acute renal disease, urinary retention
• Pheochromocytoma
• Thyrotoxicosis
• Persistent, excessive supine hypertension

Precautions

Use cautiously in:
• renal or hepatic impairment, diabetes mellitus, vision problems
• pregnant or breastfeeding patients.

Administration

• Don't give within 4 hours of bedtime.

Adverse reactions

CNS: paresthesia

CV: vasodilation, bradycardia, supine hypertension

GI: abdominal pain, dry mouth

GU: urinary retention, frequency, or urgency

Skin: rash, pruritus, piloerection

Other: chills, increased pain

Interactions

Drug-drug.Alpha- and beta-adrenergic blockers, cardiac glycosides, steroids: increased risk of bradycardia, atrioventricular block

Alpha-adrenergic blockers, fludrocortisone: increased risk of supine hypertension

Patient monitoring

• Monitor supine and sitting blood pressures closely. Report marked rise in supine blood pressure.
• Stay alert for paresthesias.
• Monitor kidney function studies and fluid intake and output. Watch for urinary frequency, urgency, or retention.

Patient teaching

Instruct patient to take while in upright position.
• Tell patient to take first dose as soon as he arises for the day, second dose at midday, and third dose in late afternoon (before 6 P.M.). Stress that doses must be taken at least 3 hours apart. Advise patient not to take drug after dinner or within 4 hours of bedtime.

Instruct patient to promptly report symptoms of supine hypertension (pounding in ears, blurred vision, headache).
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration, vision, and alertness.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs mentioned above.

References in periodicals archive ?
ProAmatine [R] should not be used in patients with persistent and excessive supine hypertension.
Shire has little incentive to conduct new trials since the entry of generics in 2003 cut into ProAmatine sales, but the disease area does seem to be an attractive one for orphan drug developers.
Last Monday the FDA issued a letter to Shire and several drugmakers that market generic versions of ProAmatine, proposing a withdrawal of the drug from the market.
Shire, the NDA holder for ProAmatine, remains committed to ensuring midodrine remains available for patients who critically need this medicine and who would be left without alternative treatments should it be withdrawn from the market.
Sales of PROAMATINE, for the year ended 31 December 2003 were $49.
Customer de-stocking subsequent to the anticipated launch of generic copies of PROAMATINE in the fourth quarter of 2003, contributed heavily to the decline in revenues between years.
AGRYLIN, PENTASA and PROAMATINE were lower, as predicted, as wholesalers
The Company estimates that Q3 2003 product sales were broadly in line with prescription-based demand for the quarter, however, reported sales of ADDERALL, AGRYLIN, PENTASA and PROAMATINE were lower, as predicted, as wholesalers reduced inventories.
1 IMS Prescription Data - ADHD market 2 IMS Prescription Data - extended release carbamazepine market 3 IMS Prescription Data - AGRYLIN, Hydrea, generic hydroxyurea market 4 IMS Prescription Data - mesalamine / olsalazine market 5 IMS Prescription Data - PROAMATINE and fludrocortisone acetate market 6 IMS Prescription Data - Product specific 7 GSK OVERVIEW OF US GAAP FINANCIAL RESULTS Introduction
The US prescription market1 for PROAMATINE and Florinef prescriptions(1) indicates that PROAMATINE had a 25% share(1) for the month of September 2002 compared to 24% in September 2001.
The US prescription market for PROAMATINE and Florinef prescriptions indicates that PROAMATINE had a 23.