Nymalize

Nymalize is a prescription medicine used to treat patients experiencing symptoms of ruptured blood vessels in the brain (subarachnoid hemorrhage, or SAH). Nymalize belongs to a group of drugs called calcium channel blockers, which relax blood vessels, making it easier for blood to flow into the injured brain tissue.

This medication comes in an oral solution (liquid). It is taken 6 times a day 21 days after an SAH event.

Common side effects of Nymalize include decreased blood pressure, headache, and nausea. Nymalize can cause dizziness. Do not drive or operate heavy machinery until you know how Nymalize affects you.

Nymalize is a prescription medication used to treat patients experiencing symptoms resulting from ruptured blood vessels in the brain (subarachnoid hemorrhage). A subarachnoid hemorrhage is serious, life threatening bleeding that occurs in the subarachnoid space – the area between the brain and the thin tissues that cover the brain.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Arbor Pharmaceuticals, Inc.

Serious side effects have been reported with Nymalize. See "Drug Precautions" section.

The most common side effects reported in clinical trials include:

• decreased blood pressure
• dizziness
• headache
• nausea
• slower than normal heartbeat
• rash

This is not a complete list of Nymalize side effects. Ask your doctor or pharmacist for more information. 

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• macrolide antibiotics such as clarithromycin (Biaxin) and telithromycin (Ketek)
• HIV protease inhibitors such as indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase)
• some HCV protease inhibitors such as boceprevir (Victrelis) and telaprevir (Incivek)
• some azole antimycotics such as ketoconazole (Nizoral), itraconazole (Onmel, Sporanox), posaconazole (Noxafil), and voriconazole (Vfend)
• conivaptan (Vaprisol)
• delavirdine (Rescriptor)
• nefazodone (Serzone)
• carbamazepine (Tegretol, Equetro, Carbatrol)
• phenobarbital
• phenytoin (Dilantin)
• rifampin (Rifadin)
• St John’s wort
• blood pressure lowering medications, including diuretics, beta-blockers, ACE inhibitors, angiotensin receptor blockers (ARBs), other calcium channel blockers, α-adrenergic blockers, PDE5 inhibitors, and α-methyldopa. Ask your pharmacist if you are taking these type of medications.

This is not a complete list of Nymalize drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Nymalize including:

• hypotension. Hypotension, or low blood pressure, may cause you to feel faint or dizzy. Inadequate fluid intake, excessive sweating, diarrhea, or vomiting can lead to an excessive fall in blood pressure, too. Lie down if you feel faint or dizzy. Call your doctor right away.
• cirrhosis (scarring of the liver). People already diagnosed with cirrhosis are at an increased risk of serious side effects. Your doctor may want to monitor blood pressure and pulse rate closely and administer a lower dosage of Nymalize.

Nymalize can cause dizziness. Do not drive or operate heavy machinery until you know how Nymalize affects you.

Grapefruit and grapefruit juice may interact with Nymalize and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before taking Nymalize, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have liver problems
• have kidney problems
• have heart problems
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Nymalize falls into category  C. There are no well-controlled studies in pregnant women. Nymalize should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Nymalize crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Nymalize.

• Take Nymalize exactly as prescribed.
• This medication can be taken orally (by mouth) or through the nasogastric tube or gastric tube route. Nymalize should NOT be given intravenously or by other parenteral routes.
• Begin Nymalize within 96 hours of the onset of subarachnoid hemorrhage (SAH).
• Take medication 1 before a meal or 2 hours after a meal.
• Capsules should be swallowed whole with a little liquid.

How to give Nymalize via a nasogastric tube or gastric tube:

• Using the supplied oral syringe labeled “ORAL USE ONLY”, administer 20 mL (60 mg) every 4 hours into a nasogastric or gastric tube for 21 consecutive days. For each dose, refill the syringe with 20 mL of 0.9% saline solution and then flush any remaining contents from nasogastric or gastric tube into the stomach.
• If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Nymalize at the same time.

The recommended oral dosage of Nymalize is 60 mg (20 mL) every 4 hours for 21 consecutive days. 

For people with cirrhosis (scarring of the liver), the dose of Nymalize is reduced to 30 mg (10 mL) every 4 hours.

If you take too much Nymalize, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store oral solution at room temperature between 15ºC to 30ºC (59ºF to 86ºF).
• Protect from light.
• Do not refrigerate.
• Keep this and all medications out of the reach of children.