Family Wellness Childrens Ibuprofen
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Side Effects & Adverse Reactions
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Uses
Amlodipine and benazepril hydrochloride capsules, USP are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.
History
There is currently no drug history available for this drug.
Other Information
Amlodipine and benazepril hydrochloride capsules, USP are a combination of amlodipine besylate, USP and benazepril hydrochloride, USP.
Benazepril hydrochloride, USP is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride’s chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is:
Its molecular formula is C24H28N2O5•HCl, and its molecular weight is 460.96.
Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group.
Amlodipine besylate, USP is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is:
Its molecular formula is C20H25ClN2O5•C6H6O3S, and its molecular weight is 567.1.
Amlodipine besylate, USP is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker.
Amlodipine and benazepril hydrochloride capsules, USP are formulated in six different strengths for oral administration with a combination of amlodipine besylate, USP equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride, USP providing for the following available combinations: 2.5/10 mg, 5/10 mg, 5/20 mg, 5/40 mg, 10/20 mg and 10/40 mg.
The inactive ingredients of the capsules are microcrystalline cellulose, talc, and hard gelatin capsules. The capsule shells for the different strengths contain the following ingredients:
2.5 mg/10 mg: gelatin and titanium dioxide
5 mg/40 mg and 10 mg/40 mg: FD&C Blue # 2, gelatin and titanium dioxide
5 mg/20 mg: gelatin, iron oxide red and titanium dioxide
10 mg/20 mg: D&C Red # 28, FD&C Blue # 1, FD&C Red # 40, gelatin and titanium dioxide
5 mg/10 mg: gelatin, iron oxide black, iron oxide red, iron oxide yellow and titanium dioxide
The capsules are imprinted with edible black ink comprised of ammonium hydroxide , iron oxide black, propylene glycol and shellac.
Sources
Family Wellness Childrens Ibuprofen Manufacturers
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Family Dollar Services Inc
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Family Wellness Childrens Ibuprofen | Apotex Corp.
2.1 General ConsiderationsThe recommended initial dose of amlodipine and benazepril hydrochloride is one capsule of amlodipine 2.5 mg/benazepril 10 mg orally once-daily.
It is usually appropriate to begin therapy with amlodipine and benazepril hydrochloride only after a patient has either (a) failed to achieve the desired antihypertensive effect with amlodipine or benazepril monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema.
The antihypertensive effect of amlodipine and benazepril hydrochloride is largely attained within 2 weeks. If blood pressure remains uncontrolled, the dose may be titrated up to amlodipine 10 mg/benazepril 40 mg once-daily. The dosing should be individualized and adjusted according to the patient’s clinical response.
Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5 to 10 mg while benazepril is effective in doses of 10 to 80 mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5 to 10 mg and benazepril doses of 10 to 40 mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups.
2.2 Dosage Adjustment in Renal ImpairmentRenal Impairment: Amlodipine and benazepril hydrochloride is not recommended in patients with creatinine clearance (CrCl) ≤30 mL/min. No dose adjustment of amlodipine and benazepril hydrochloride is required in patients with CrCl >30 mL/min/1.73 m2 (serum creatinine roughly ≤3 mg/dL or 265 micromol/L) [see Warnings and Precautions (5.7), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
2.3 Replacement TherapyAmlodipine and benazepril hydrochloride capsules may be substituted for the titrated components.
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