Dihydroergotamine Mesylate (Dihydroergotamine Mesylate)

Trade Name : Dihydroergotamine Mesylate

West-Ward Pharmaceuticals Corp

INJECTION

Strength 1 mg/mL

DIHYDROERGOTAMINE MESYLATE Ergotamines [CS],Ergotamine Derivative [EPC]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Dihydroergotamine Mesylate (Dihydroergotamine Mesylate) which is also known as Dihydroergotamine Mesylate and Manufactured by West-Ward Pharmaceuticals Corp. It is available in strength of 1 mg/mL per ml. Read more

Dihydroergotamine Mesylate (Dihydroergotamine Mesylate) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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WARNING
Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of DIHYDROERGOTAMINE with potent CYP 3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP 3A4 inhibition elevates the serum levels of DIHYDROERGOTAMINE, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of these medications is contraindicated. n

Dihydroergotamine Mesylate Injection, USP is ergotamine hydrogenated in the 9, 10 position as the mesylate salt. Dihydroergotamine Mesylate Injection, USP u00a0is known chemically as ergotaman-3u00b4,6u00b4,18-trione,9,10-dihydro-12u00b4-hydroxy-2u00b4-methyl-5u00b4-(phenylmethyl)-,(5u00b4u03b1)-, monomethanesulfonate. Its molecular weight is 679.80 and its empirical formula is CHNOu2022CHOS.
The chemical structure is
Dihydroergotamine mesylateCHNOu2022CHOSu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Mol. wt. 679.80
Dihydroergotamine Mesylate Injection, USP is a clear, colorless solution supplied in sterile ampules for intravenous, intramuscular, or subcutaneous administration. Each mL contains 1 mg Dihydroergotamine Mesylate, USP; Alcohol, USP 6.1% by volume at 60u00baF; Glycerin, USP 15% by weight; Water for injection, USP; Methanesulfonic Acid and/or Sodium Hydroxide. pH range is 3.4 - 4.9.

No data

Dihydroergotamine Mesylate Injection, USP is indicated for the acute treatment of migraine headaches with or without aura and the acute treatment of cluster headache episodes.

There have been a few reports of serious adverse events associated with the coadministration of dihydroergotamine and potent CYP 3A4 inhibitors, such as protease inhibitors and macrolide antibiotics, resulting in vasospasm that led to cerebral ischemia and/or ischemia of the extremities. The use of potent CYP 3A4 inhibitors (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin, ketoconazole, itraconazole) with dihydroergotamine is, therefore contraindicated ().
Dihydroergotamine mesylate injection should not be given to patients with ischemic heart disease (angina pectoris, history of myocardial infarction, or documented silent ischemia) or to patients who have clinical symptoms or findings consistent with coronary artery vasospasm including Prinzmetal's variant angina. (.)
Because dihydroergotamine mesylate injection may increase blood pressure, it should not be given to patients with uncontrolled hypertension.
Dihydroergotamine mesylate injection, 5-HT agonists (e.g., sumatriptan), ergotamine-containing or ergot-type medications or methysergide should not be used within 24 hours of each other.
Dihydroergotamine mesylate injection should not be administered to patients with hemiplegic or basilar migraine.
In addition to those conditions mentioned above, dihydroergotamine mesylate injection is also contraindicated in patients with known peripheral arterial disease, sepsis, following vascular surgery and severely impaired hepatic or renal function.
Dihydroergotamine mesylate injection may cause fetal harm when administered to a pregnant woman. Dihydroergotamine possesses oxytocic properties and, therefore, should not be administered during pregnancy. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
There are no adequate studies of dihydroergotamine in human pregnancy, but developmental toxicity has been demonstrated in experimental animals. In embryo-fetal development studies of dihydroergotamine mesylate nasal spray, intranasal administration to pregnant rats throughout the period of organogenesis resulted in decreased fetal body weights and/or skeletal ossification at doses of 0.16 mg/day (associated with maternal plasma dihydroergotamine exposures [AUC] approximately 0.4-1.2 times the exposures in humans receiving the MRDD of 4 mg) or greater. A no effect level for embryo-fetal toxicity was not established in rats. Delayed skeletal ossification was also noted in rabbit fetuses following intranasal administration of 3.6 mg/day (maternal exposures approximately 7 times human exposures at the MRDD) during organogenesis. A no effect level was seen at 1.2 mg/day (maternal exposures approximately 2.5 times human exposures at the MRDD). When dihydroergotamine mesylate nasal spray was administered intranasally to female rats during pregnancy and lactation, decreased body weights and impaired reproductive function (decreased mating indices) were observed in the offspring at doses of 0.16 mg/day or greater. A no effect level was not established. Effects on development occurred at doses below those that produced evidence of significant maternal toxicity in these studies. Dihydroergotamine-induced intrauterine growth retardation has been attributed to reduced uteroplacental blood flow resulting from prolonged vasoconstriction of the uterine vessels and/or increased myometrial tone.
Dihydroergotamine mesylate injection is contraindicated in patients who have previously shown hypersensitivity to ergot alkaloids.
Dihydroergotamine mesylate should not be used by nursing mothers. ()
Dihydroergotamine mesylate should not be used with peripheral and central vasoconstrictors because the combination may result in additive or synergistic elevation of blood pressure.
u00a0

Dihydroergotamine mesylate injection should only be used where a clear diagnosis of migraine headache has been established.
CYP 3A4 Inhibitors (e.g. Macrolide Antibiotics and Protease Inhibitors)
There have been rare reports of serious adverse events in connection with the coadministration of dihydroergotamine and potent CYP 3A4 inhibitors, such as protease inhibitors and macrolide antibiotics, resulting in vasospasm that led to cerebral ischemia and/or ischemia of the extremities. The use of potent CYP 3A4 inhibitors with dihydroergotamine should therefore be avoided (). Examples of some of the more potent CYP 3A4 inhibitors include: anti-fungals ketoconazole and itraconazole, the protease inhibitors ritonavir, nelfinavir, and indinavir, and macrolide antibiotics erythromycin, clarithromycin, and troleandomycin. Other less potent CYP 3A4 inhibitors should be administered with caution. Less potent inhibitors include saquinavir, nefazodone, fluconazole, grapefruit juice, fluoxetine, fluvoxamine, zileuton, and clotrimazole. These lists are not exhaustive, and the prescriber should consider the effects on CYP 3A4 of other agents being considered for concomitant use with dihydroergotamine.
Fibrotic Complications
There have been reports of pleural and retroperitoneal fibrosis in patients following prolonged daily use of injectable dihydroergotamine mesylate. Rarely, prolonged daily use of other ergot alkaloid drugs has been associated with cardiac valvular fibrosis. Rare cases have also been reported in association with the use of injectable dihydroergotamine mesylate; however, in those cases, patients also received drugs known to be associated with cardiac valvular fibrosis.
Administration of dihydroergotamine mesylate injection, should not exceed the dosing guidelines and should not be used for chronic daily administration ().
Risk of Myocardial Ischemia and/or Infarction and Other Adverse Cardiac Events
Dihydroergotamine mesylate injection should not be used by patients with documented ischemic or vasospastic coronary artery disease. (.) It is strongly recommended that dihydroergotamine mesylate injection not be given to patients in whom unrecognized coronary artery disease (CAD) is predicted by the presence of risk factors (e.g., hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of CAD, females who are surgically or physiologically postmenopausal, or males who are over 40 years of age) unless a cardiovascular evaluation provides satisfactory clinical evidence that the patient is reasonably free of coronary artery and ischemic myocardial disease or other significant underlying cardiovascular disease. The sensitivity of cardiac diagnostic procedures to detect cardiovascular disease or predisposition to coronary artery vasospasm is modest, at best. If, during the cardiovascular evaluation, the patient's medical history or electrocardiographic investigations reveal findings indicative of or consistent with coronary artery vasospasm or myocardial ischemia, dihydroergotamine mesylate injection should not be administered. (.)
For patients with risk factors predictive of CAD who are determined to have a satisfactory cardiovascular evaluation, it is strongly recommended that administration of the first dose of dihydroergotamine mesylate injection, USP take place in the setting of a physician's office or similar medically staffed and equipped facility unless the patient has previously received dihydroergotamine mesylate. Because cardiac ischemia can occur in the absence of clinical symptoms, consideration should be given to obtaining on the first occasion of use an electrocardiogram (ECG) during the interval immediately following dihydroergotamine mesylate injection, in those patients with risk factors.
It is recommended that patients who are intermittent long-term users of dihydroergotamine mesylate injection and who have or acquire risk factors predictive of CAD, as described above, undergo periodic interval cardiovascular evaluation as they continue to use dihydroergotamine mesylate injection .
The systematic approach described above is currently recommended as a method to identify patients in whom dihydroergotamine mesylate injection may be used to treat migraine headaches with an acceptable margin of cardiovascular safety.
Cardiac Events and Fatalities
The potential for adverse cardiac events exists. Serious adverse cardiac events, including acute myocardial infarction, life-threatening disturbances of cardiac rhythm, and death have been reported to have occurred following the administration of dihydroergotamine mesylate injection. Considering the extent of use of dihydroergotamine mesylate in patients with migraine, the incidence of these events is extremely low.
Drug-Associated Cerebrovascular Events and Fatalities
Cerebral hemorrhage, subarachnoid hemorrhage, stroke, and other cerebrovascular events have been reported in patients treated with dihydroergotamine mesylate injection; and some have resulted in fatalities. In a number of cases, it appears possible that the cerebrovascular events were primary, the dihydroergotamine mesylate injection having been administered in the incorrect belief that the symptoms experienced were a consequence of migraine, when they were not. It should be noted that patients with migraine may be at increased risk of certain cerebrovascular events (e.g., stroke, hemorrhage, transient ischemic attack).
Other Vasospasm Related Events
Dihydroergotamine mesylate injection, like other ergot alkaloids, may cause vasospastic reactions other than coronary artery vasospasm. Myocardial, peripheral vascular, and colonic ischemia have been reported with dihydroergotamine mesylate injection.
Dihydroergotamine mesylate injection associated vasospastic phenomena may also cause muscle pains, numbness, coldness, pallor, and cyanosis of the digits. In patients with compromised circulation, persistent vasospasm may result in gangrene or death. Dihydroergotamine mesylate injection should be discontinued immediately if signs or symptoms of vasoconstriction develop.
Increase In Blood Pressure
Significant elevation in blood pressure has been reported on rare occasions in patients with and without a history of hypertension treated with dihydroergotamine mesylate injection. Dihydroergotamine mesylate injection is contraindicated in patients with uncontrolled hypertension. (.)
An 18% increase in mean pulmonary artery pressure was seen following dosing with another 5-HT agonist in a study evaluating subjects undergoing cardiac catheterization.

No data

Serious cardiac events, including some that have been fatal, have occurred following use of dihydroergotamine mesylate injection, but are extremely rare. Events reported have included coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation. (See , , and .). Fibrotic complications have been reported in association with long term use of injectable dihydroergotamine mesylate ().
Post-introduction Reports
The following events derived from postmarketing experience have been occasionally reported in patients receiving dihydroergotamine mesylate injection: vasospasm, paraesthesia, hypertension, dizziness, anxiety, dyspnea, headache, flushing, diarrhea, rash, increased sweating, and pleural and retroperitoneal fibrosis after long-term use of dihydroergotamine. Extremely rare cases of myocardial infarction and stroke have been reported. A causal relationship has not been established.
Dihydroergotamine mesylate injection is not recommended for prolonged daily use. (n )
To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp at 1-877-233-2001 or FDA at 1-800-FDA-1088 or n- Arrayn- Array
u00a0

Currently available data have not demonstrated drug abuse or psychological dependence with dihydroergotamine. However, cases of drug abuse and psychological dependence in patients on other forms of ergot therapy have been reported. Thus, due to the chronicity of vascular headaches, it is imperative that patients be advised not to exceed recommended dosages.

To date, there have been no reports of acute overdosage with this drug. Due to the risk of vascular spasm, exceeding the recommended dosages of dihydroergotamine mesylate injection is to be avoided. Excessive doses of dihydroergotamine may result in peripheral signs and symptoms of ergotism. Treatment includes discontinuance of the drug, local application of warmth to the affected area, the administration of vasodilators, and nursing care to prevent tissue damage.
In general, the symptoms of an acute dihydroergotamine mesylate injection overdose are similar to those of an ergotamine overdose, although there is less pronounced nausea and vomiting with dihydroergotamine mesylate injection. The symptoms of an ergotamine overdose include the following: numbness, tingling, pain, and cyanosis of the extremities associated with diminished or absent peripheral pulses; respiratory depression; an increase and/or decrease in blood pressure, usually in that order; confusion, delirium, convulsions, and coma; and/or some degree of nausea, vomiting, and abdominal pain.
In laboratory animals, significant lethality occurs when dihydroergotamine is given at I.V. doses of 44 mg/kg in mice, 130 mg/kg in rats, and 37 mg/kg in rabbits.
Up-to-date information about the treatment of overdosage can often be obtained from a certified Regional Poison Control Center. Telephone numbers of certified Poison Control Centers are listed in the Physician's Desk Referenceu00ae (PDR).

Dihydroergotamine mesylate injection should be administered in a dose of 1 mL intravenously, intramuscularly or subcutaneously. The dose can be repeated, as needed, at 1 hour intervals to a total dose of 3 mL for intramuscular or subcutaneous delivery or 2 mL for intravenous delivery in a 24 hour period. The total weekly dosage should not exceed 6 mL. Dihydroergotamine mesylate injection, should not be used for chronic daily administration.

Dihydroergotamine Mesylate Injection, USP
Available as a clear, colorless, sterile solution in single 1 mL sterile ampules containing 1 mg of dihydroergotamine mesylate per mL, in packages of 10 (NDC 0143-9273-10).
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted to 15u00ba to 30u00baC (59u00ba to 86u00baF) [See USP Controlled Room Temperature], in light-resistant containers.
Do not refrigerate or freeze. To assure constant potency, protect the ampules from light and heat. Administer only if clear and colorless.

Information for the Patient
Dihydroergotamine Mesylate Injection, USP
Before self-injecting Dihydroergotamine Mesylate Injection, USP by subcutaneous administration, you will need to obtain professional instruction on how to properly administer your medication. Below are some of the steps you should follow carefully. Read this leaflet completely before using this medication.
This leaflet does not contain all of the information on Dihydroergotamine Mesylate Injection, USP. Your pharmacist and/or health care provider can provide more detailed information.
Purpose of your Medication
Dihydroergotamine Mesylate Injection, USP is intended to treat an active migraine headache. Do not try to use it to prevent a headache if you have no symptoms. Do not use it to treat common tension headache or a headache that is not at all typical of your usual migraine headache. Administration of Dihydroergotamine Mesylate Injection, USP should not exceed the dosing guidelines and should not be used for chronic daily administration. There have been reports of fibrosis (stiffening) in the lung or kidney areas in patients following prolonged daily use of injectable dihydroergotamine mesylate. Rarely, prolonged daily use of other ergot alkaloid drugs (the class of drugs to which Dihydroergotamine Mesylate Injection, USP belongs) has been associated with heart valvular fibrosis. u00a0Rare cases have also been reported in association with the use of injectable dihydroergotamine mesylate; however, in those cases, patients also received drugs known to be associated with heart valvular fibrosis.
Do not use Dihydroergotamine Mesylate Injection, USP if you:
u00a0
Important questions to consider before using
Dihydroergotamine Mesylate Injection, USP
Please answer the following questions before you use your Dihydroergotamine Mesylate Injection, USP.
If you answer YES to any of these questions or are unsure of the answer, you should talk to your doctor before using Dihydroergotamine Mesylate Injection, USP.
Serious or potentially life-threatening reductions in blood flow to the brain or extremities have been reported rarely due to interactions between Dihydroergotamine Mesylate Injection, USP and protease inhibitors or macrolide antibiotics.
REMEMBER TO TELL YOUR DOCTOR IF YOU HAVE ANSWERED YES TO ANY OF THESE QUESTIONS BEFORE YOU USE Dihydroergotamine Mesylate Injection, USP
Side Effects To Watch Out For
Although the following reactions rarely occur, they can be serious and should be reported to your physician immediately:
Dosage
Your doctor will have told you what dose to use for each migraine attack. Should you get another migraine attack in the same day as the attack you treated, you must not treat it with Dihydroergotamine Mesylate Injection, USP unless at least 6 hours have elapsed since your last injection. No more than 6 mL of Dihydroergotamine Mesylate Injection, USP should be injected during a one-week period. Dihydroergotamine Mesylate Injection, USP is not intended to be used on a prolonged daily basis.
Learn what to do in case of an Overdose
If you have used more medication than you have been instructed, contact your doctor, hospital emergency department, or nearest poison control center immediately.
How to use the Dihydroergotamine Mesylate Injection, USP
A. Wash your hands thoroughly with soap and water.
B. Check the dose of your medication.
C. Look to see if there is any liquid at the top of the ampule. If there is, gently flick the ampule with your finger to get all the liquid into the bottom portion of the ampule.
D. Hold the bottom of the ampule in one hand. Clean the ampule neck with an alcohol wipe using the other hand. To break, place the alcohol wipe around the neck of the ampule and break it open by pressing your thumb against the neck of the ampule.
E. Tilt the ampule down at a 45u00ba angle. Insert the needle into the solution in the ampule.
F. Draw up the medication by pulling back the plunger slowly and steadily until you reach your dose.
G. Check the syringe for air bubbles. Hold it with the needle pointing upward. If there are air bubbles, tap your finger against the barrel of the syringe to get the bubbles to the top. Slowly and carefully push the plunger up so that the bubbles are pushed out through the needle and you see a drop of medication.
H. When there are no air bubbles, check the dose of the medication. If the dose is incorrect, repeat steps E, F, G and H until you draw up the right dose.
Check the expiration date printed on the ampule containing medication. If the expiration date has passed, do not use it.
Answers to Patients' Questions About Dihydroergotamine Mesylate Injection, USP
What if I need help in using my Dihydroergotamine Mesylate Injection, USP?
If you have any questions or if you need help in opening, putting together, or using Dihydroergotamine Mesylate Injection, USP, speak to your doctor or pharmacist.
How much medication should I use and how often?
Your doctor will have told you what dose to use for each migraine attack. Should you get another migraine attack in the same day as the attack you treated, you must not treat it with Dihydroergotamine Mesylate Injection, USP unless at least 6 hours have elapsed since your last injection. No more than 6 mL of Dihydroergotamine Mesylate Injection, USP should be injected during a one-week period. Do not use more than this amount unless instructed to do so by your doctor. Dihydroergotamine Mesylate Injection, USP is not intended for chronic daily use.
If you have any other unanswered questions about Dihydroergotamine Mesylate Injection, USP, consult your doctor or pharmacist.

Manufactured by:
Hikma Farmacu00eautica (Portugal), S.A.
Estrada do Rio da Mu00f3 8, 8A e 8B u2013 Fervenu00e7au00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
2705-906 Terrugem u2013 Sintra
Portugal
Distributed by:
WEST-WARD
A HIKMA COMPANY
EATONTOWN NJ 07724
U.S.A.
Revised: September 2017
PIN482-WES/1

1 mL Single Dose AmpuleNDC 0143-9273-01DihydroergotamineMesylate Injection, USP1 mg/mLFOR IV, IM OR SC USERx ONLY

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Dihydroergotamine Mesylate (Dihydroergotamine Mesylate)

Trade Name : Dihydroergotamine Mesylate

INJECTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Dihydroergotamine Mesylate (Dihydroergotamine Mesylate)

Trade Name : Dihydroergotamine Mesylate

INJECTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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