Nimodipine is a dihydropyridine calcium channel blocker sold in the U.S. under 2 brand and generic names, for subarachnoid hemorrhage. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Nymalize (application NDA203340). Other nimodipine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Administer only enterally (e.g., oral, nasogastric tube, or gastric tube route). Do not administer intravenously or by other parenteral routes. ( 2.1 ) Give one hour before a meal or two hours after a meal. ( 2.1 ) Start dosing within 96 hours of the SAH. ( 2.1 ) Recommended dose is 10 mL (60 mg) every 4 hours for 21 consecutive days. ( 2.2 ) Nasogastric or Gastric Tube Administration: Administer 10 mL (60 mg) every 4 hours with supplied prefilled oral syringe. Refill syringe with 10 mL of 0.9% saline water solution; flush remaining contents from nasogastric or gastric tube into stomach. ( 2.3 ) Patients with Cirrhosis: Reduce dosage to 5 mL (30 mg) every 4 hours. ( 2.4 ) 2.1 Administration Instructions Administer only enterally (e.g., oral, nasogastric tube, or gastric tube route). Do not administer intravenously or by other parenteral routes. For all routes of administration, begin NYMALIZE within 96 hours of the onset of SAH. Administer one hour before a meal or two hours after a meal for all routes of administration [see Clinical Pharmacology (12.3) ] . 2.2 Administration by Oral Route The recommended oral dosage is 10 mL (60 mg) every 4 hours for 21 consecutive days. 2.3 Administration Via Nasogastric or Gastric Tube Using the supplied prefilled oral syringe labeled "For Oral Use Only", administer 10 mL (60 mg) every 4 hours into a nasogastric or gastric tube for 21…
The safety and efficacy of NYMALIZE (nimodipine oral solution) in the treatment of patients with SAH is based on adequate and well-controlled studies of nimodipine oral capsules in patients with SAH. NYMALIZE (nimodipine oral solution) has comparable bioavailability to nimodipine oral capsules. The following clinically significant adverse reaction appears in other sections of the labeling: Hypotension [see Warnings and Precautions (5.1) ]. Most common adverse reactions (incidence ≥1% and ≥1% placebo) were hypotension, headache, nausea, and bradycardia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In clinical trials of nimodipine oral capsules in patients with SAH, eleven percent (92 of 823) of nimodipine-treated patients reported adverse events compared to six percent (29 of 479) of placebo-treated patients. The most common adverse event was decreased blood pressure in 4.4% of nimodipine-treated patients. The events reported with a frequency greater than 1% are displayed…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Solution | Generic | $40 | View → | |
| 2 | Not yet rated | Prescription | Capsule | Generic | $40 |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| NM1 | 30 mg | white | capsule | — |
| HP512 | 30 mg | orange | capsule | — |
| A297 | 30 mg | gray | capsule | — |
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
None. None ( 4 )
Anti-Hypertensives : May increase risk of hypotension. Monitor blood pressure. ( 7.1 ) CYP3A4 Moderate and Weak Inhibitors: May increase risk of hypotension. Monitor blood pressure. Dose reduction of NYMALIZE may be needed. Avoid grapefruit juice. ( 7.2 ) CYP3A4 Moderate and Weak Inducers: May reduce efficacy of NYMALIZE. Dose increase may be needed. ( 7.3 ) 7.1 Blood Pressure Lowering Drugs Nimodipine may increase the blood pressure lowering effect of concomitantly administered anti-hypertensives such as diuretics, beta-blockers, ACE inhibitors, angiotensin receptor blockers, other calcium channel blockers, α-adrenergic blockers, PDE5 inhibitors, and α-methyldopa. In Europe, nimodipine was observed to occasionally intensify the effect of antihypertensive drugs taken concomitantly by hypertensive patients; this phenomenon was not observed in North American clinical trials. Blood pressure should be carefully monitored, and dose adjustment of the blood pressure lowering drug(s) may be necessary. 7.2 CYP3A4 Inhibitors Nimodipine plasma concentration can be significantly increased when concomitantly administered with strong CYP3A4 inhibitors. As a consequence, the blood pressure lowering effect may be increased. Therefore, the concomitant administration of NYMALIZE and strong CYP3A4 inhibitors should generally be avoided [ see Warnings and Precautions (5.3) ]. Strong CYP3A4…