midodrine hydrochloride

(redirected from Amatine)

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 ?
Vukovich, Chairman and CEO of Roberts, commented on the financial performance of the Company by stating, "Roberts has achieved six straight quarters of profits while continuing to fund a significant level of R&D activity in support of our ongoing effort to obtain FDA approval for AMATINE, for hypotension, AGRELIN, for excessive platelet production, and MAXIVENT, an oral bronchodilator.
AMATINE is currently being marketed in Canada under an exclusive distribution agreement with Boots Pharmaceuticals.
We continue to look toward our goal of achieving profitability while concentrating our efforts on the near-term launch of SUPPRELIN, the continued support of our AMATINE program, and the increased development activities of MAXIVENT, AGRELIN and SOMAGARD, as these products move closer toward FDA review.
Fetnat Fouad-Terazi will report at the meeting in Dallas that eight patients with the disabling condition of orthostatic hypotension, who had difficulty standing upright because of low blood pressure, were treated with Amatine or a comparative drug ephedrine in a double-blind study at the Cleveland Clinic.
However, Amatine has been successfully used in Europe for 10 years.
ROBERTS PHARMACEUTICALS NOTIFIED OF AMATINE APPROVABILITY IN NEW ZEALAND
This relationship will be of significant advantage to our company when we receive FDA approval for Amatine, another product to be promoted to neurologists.
A New Drug Application has been filed with the Food and Drug Administration for Amatine in the United States.