Mecamylamine (Inversine)
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Mecamylamine (Inversine)

INVERSINE®
(mecamylamine HCl)

DRUG DESCRIPTION

INVERSINE® (Mecamylamine HCl) is a potent, oral antihypertension agent and ganglion blocker, and is a secondary amine. It is N,2,3,3-tetramethyl-bicyclo (2.2.1] heptan- 2 -amine hydrochloride. Its empirical formula is C11H21N • HCI and its structural formula is:

Inversine (Mecamylamine HCI) Structural Formula Illustration

It is a white, odorless, or practically odorless, crystalline powder, is highly stable, soluble in water and has a molecular weight of 203.75.

INVERSINE (mecamylamine) is supplied as tablets for oral use, each containing 2.5 mg mecamylamine HCI. Inactive ingredients are acacia, calcium phosphate, D&C Yellow 10, FD&C Yellow 6, lactose, magnesium stearate, starch, and talc.

What are the possible side effects of mecamylamine (Inversine)?

If you experience any of the following serious side effects, stop taking mecamylamine and seek emergency medical attention:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives); or
  • abdominal pain, abdominal distention, or diarrhea.

Other, less serious side effects may be more likely to occur. Continue to take mecamylamine and talk to your doctor if you experience

  • nausea, vomiting, or constipation;
  • dry mouth;
  • decreased appetite;
  • dizziness and...

Read All Potential Side Effects and See Pictures of Inversine »

Last reviewed on RxList: 12/2/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

For the management of moderately severe to severe essential hypertension and in uncomplicated cases of malignant hypertension.

DOSAGE AND ADMINISTRATION

Therapy is usually started with one 2.5 mg tablet of INVERSINE (mecamylamine) twice a day. This initial dosage should be modified by increments of one 2.5 mg tablet at intervals of not less than 2 days until the desired blood pressure response occurs (the criterion being a dosage just under that which causes signs of mild postural hypotension).

The average total daily dosage of INVERSINE (mecamylamine) is 25 mg, usually in three divided doses. However, as little as 2.5 mg daily may be sufficient to control hypertension in some patients. A range of two to four or even more doses may be required in severe cases when smooth control is difficult to obtain. In severe or urgent cases, larger increments at smaller intervals may be needed. Partial tolerance may develop in certain patients, requiring an increase in the daily dosage of INVERSINE (mecamylamine) .

Administration of INVERSINE (mecamylamine) after meals may cause a more gradual absorption and smoother control of excessively high blood pressure. The timing of doses in relation to meals should be consistent. Since the blood pressure response to antihypertensive drugs is increased in the early morning, the larger dose should be given at noontime and perhaps in the evening. The morning dose, as a rule, should be relatively small and in some instances may even be omitted.

The initial regulation of dosage should be determined by blood pressure readings in the erect position at the time of maximal effect of the drug, as well as by other signs and symptoms of orthostatic hypotension.

The effective maintenance dosage should be regulated by blood pressure readings in the erect position and by limitation of dosage to that which causes slight faintness or dizziness in this position. If the patient or a relative can use a sphygmomanometer, instructions may be given to reduce or omit a dose if readings fall below a designated level or if faintness or lightheadedness occurs. However, no change should be instituted without the knowledge of the physician.

Close supervision and education of the patient, as well as critical adjustment of dosage, are essential to successful therapy.

Other Antihypertensive Agents

When INVERSINE (mecamylamine) is given with other antihypertensive drugs, the dosage of these other agents, as well as that of INVERSINE (mecamylamine) , should be reduced to avoid excessive hypotension. However, thiazides should be continued in their usual dosage, while that of INVERSINE (mecamylamine) is decreased by at least 50 percent.

HOW SUPPLIED

Tablets INVERSINE (mecamylamine) , 2.5 mg, are slightly yellow, round compressed tablets, coded LBS01. They are supplied as follows:

NDC 17205-0626-1 in bottles of 100.

Storage Condition

Store at 25°C (77°F); excursions permitted to 15-30°(59-86°F)

(see USP Controlled Room (Temperature)

Manufactured by: Siegfried CMS Ltd., Zofingen, Switzerland for Targacept, Inc., Wmston-Salem, NC 27101. FDA revision date: 10/18/2002

Last reviewed on RxList: 12/2/2008
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

The following adverse reactions have been reported and within each category are listed in order of decreasing severity.

Gastrointestinal: Ileus, constipation (sometimes preceded by small, frequent liquid stools), vomiting, nausea, anorexia glossitis and dryness of mouth.

Cardiovascular: Orthostatic dizziness and syncope, postural hypotension.

Nervous System/Psychiatric: Convulsions, choreiform movements, mental aberrations, tremor, and paresthesias (see WARNINGS).

Respiratory:Interstitial pulmonary edema and fibrosis.

Urogenital:Urinary retention, impotence, decreased libido.

Special Senses: Blurred vision, dilated pupils.

Miscellaneous: Weakness, fatigue, sedation.

Read the Inversine (mecamylamine) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Patients receiving antibiotics and sulfonamides generally should not be treated with ganglion blockers.

The action of INVERSINE (mecamylamine) may be potentiated by anesthesia, other anti hypertensive drugs and alcohol.

Last reviewed on RxList: 12/2/2008
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Mecamylamine, a secondary amine, readily penetrates into the brain and thus may produce central nervous system effects. Tremor, choreiform movements, mental aberrations, and convulsions may occur rarely. These have occurred most often when large doses of INVERSINE (mecamylamine) were used, especially in patients with cerebral or renal insufficiency.

When ganglion blockers or other potent anti hypertensive drugs are discontinued suddenly, hypertensive levels return. In patients with malignant hypertension and others, this may occur abruptly and may cause fatal cerebral vascular accidents or acute congestive heart failure. When INVERSINE (mecamylamine) is withdrawn, this should be done gradually and other anti hypertensive therapy usually must be substituted. On the other hand, the effects of INVERSINE (mecamylamine) sometimes may last from hours to days after therapy is discontinued.

PRECAUTIONS

General

The patient's condition should be evaluated carefully, particularly as to renal and cardiovascular function. When renal, cerebral, or coronary blood flow is deficient, any additional impairment, which might result from added hypotension, must be avoided. The use of INVERSINE (mecamylamine) in patients with marked cerebral and coronary arteriosclerosis or after a recent cerebral accident requires caution.

The action of INVERSINE (mecamylamine) may be potentiated by . excessive heat, fever, infection, hemorrhage, pregnancy, anesthesia, surgery, vigorous exercise, other anti hypertensive drugs, alcohol, and salt depletion as a result of diminished intake or increased excretion due to diarrhea, vomiting, excessive sweating, or diuretics.

During therapy with INVERSINE (mecamylamine) , sodium intake should not be restricted but, if necessary, the dosage of the ganglion blocker must be adjusted.

Since urinary retention may occur in patients on ganglion blockers, caution is required in patients with prostatic hypertrophy, bladder neck obstruction, and urethral stricture.

Frequent loose bowel movements with abdominal distention and decreased borborygmi may be the first signs of paralytic ileus. If these are present, INVERSINE (mecamylamine) should be discontinued immediately and remedial steps taken.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate the effects upon fertility, mutagenic or carcinogenic potential of INVERSINE (mecamylamine) .

Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with INVERSINE (mecamylamine) . It is not known whether INVERSINE (mecamylamine) can cause fetal harm when given to a pregnant woman or can affect reproductive capacity. INVERSINE (mecamylamine) should be given to a pregnant woman only if clearly needed.

Nursing Mothers

Because of the potential for serious adverse reactions in nursing infants from INVERSINE (mecamylamine) , a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Last reviewed on RxList: 12/2/2008
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

Signs of overdosage include: hypotension (which may progress to peripheral vascular collapse), postural hypotension, nausea, vomiting, diarrhea, constipation paralytic ileus, urinary retention, dizziness, anxiety, dry mouth, mydriasis, blurred vision, or palpitations. A rise in intraocular pressure may occur.

Pressor amines may be used to counteract excessive hypotension. Since patients being treated with ganglion blockers are more than normally reactive to pressor amines small doses of the latter are recommended to avoid excessive response.

The oral LD50 of mecamylamine in the mouse is 92 mg/kg.

CONTRAINDICATIONS

INVERSINE (mecamylamine) should not be used in mild, moderate, labile hypertension and may prove unsuitable in uncooperative patients. It is contraindicated in coronary insufficiency or recent myocardial infarction.

INVERSINE (mecamylamine) should be given with great discretion, if at all, when renal insufficiency is manifested by a rising or elevated BUN. The drug is contraindicated in uremia. Patients receiving antibiotics and sulfonamides should generally not be treated with ganglion blockers. Other contraindications are glaucoma, organic pyloric stenosis or hypersensitivity to the product

Last reviewed on RxList: 12/2/2008
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Mecamylamine reduces blood pressure in both normotensive and hypertensive individuals. It has a gradual onset of action (1/2 to 2 hours) and a long-lasting effect (usually 6 to 12 hours or more). A small oral dosage often produces a smooth and predictable reduction of blood pressure. Although this anti hypertensive effect is predominantly orthostatic, the supine blood pressure is also significantly reduced.

Pharmacokinetics and Metabolism

Mecamylamine is almost completely absorbed from the gastrointestinal tract, resulting in consistent lowering of blood pressure in most patients with hypertensive cardiovascular disease. Mecamylamine is excreted slowly in the urine in the unchanged form. The rate of its renal elimination is influenced markedly by urinary pH. Alkalinization of the urine reduces, and acidification promotes, renal excretion of mecamylamine.

Mecamylamine crosses the blood-brain and placental barriers.

Last reviewed on RxList: 12/2/2008
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

INVERSINE (mecamylamine) may cause dizziness, lightheadedness, or fainting, especially when rising from a lying or sitting position. This effect may be increased by alcoholic beverages, exercise, or during hot weather. Getting up slowly may help alleviate such a reaction.

Last reviewed on RxList: 12/2/2008
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

INVERSINE (mecamylamine) may cause dizziness, lightheadedness, or fainting, especially when rising from a lying or sitting position. This effect may be increased by alcoholic beverages, exercise, or during hot weather. Getting up slowly may help alleviate such a reaction.

Last reviewed on RxList: 12/2/2008
This monograph has been modified to include the generic and brand name in many instances.

INVERSINE®
(mecamylamine HCl)

DRUG DESCRIPTION

INVERSINE® (Mecamylamine HCl) is a potent, oral antihypertension agent and ganglion blocker, and is a secondary amine. It is N,2,3,3-tetramethyl-bicyclo (2.2.1] heptan- 2 -amine hydrochloride. Its empirical formula is C11H21N • HCI and its structural formula is:

Inversine (Mecamylamine HCI) Structural Formula Illustration

It is a white, odorless, or practically odorless, crystalline powder, is highly stable, soluble in water and has a molecular weight of 203.75.

INVERSINE (mecamylamine) is supplied as tablets for oral use, each containing 2.5 mg mecamylamine HCI. Inactive ingredients are acacia, calcium phosphate, D&C Yellow 10, FD&C Yellow 6, lactose, magnesium stearate, starch, and talc.

Last reviewed on RxList: 12/2/2008
This monograph has been modified to include the generic and brand name in many instances.

INVERSINE®
(mecamylamine HCl)

DRUG DESCRIPTION

INVERSINE® (Mecamylamine HCl) is a potent, oral antihypertension agent and ganglion blocker, and is a secondary amine. It is N,2,3,3-tetramethyl-bicyclo (2.2.1] heptan- 2 -amine hydrochloride. Its empirical formula is C11H21N • HCI and its structural formula is:

Inversine (Mecamylamine HCI) Structural Formula Illustration

It is a white, odorless, or practically odorless, crystalline powder, is highly stable, soluble in water and has a molecular weight of 203.75.

INVERSINE (mecamylamine) is supplied as tablets for oral use, each containing 2.5 mg mecamylamine HCI. Inactive ingredients are acacia, calcium phosphate, D&C Yellow 10, FD&C Yellow 6, lactose, magnesium stearate, starch, and talc.

Last reviewed on RxList: 12/2/2008
This monograph has been modified to include the generic and brand name in many instances.

INVERSINE®
(mecamylamine HCl)

DRUG DESCRIPTION

INVERSINE® (Mecamylamine HCl) is a potent, oral antihypertension agent and ganglion blocker, and is a secondary amine. It is N,2,3,3-tetramethyl-bicyclo (2.2.1] heptan- 2 -amine hydrochloride. Its empirical formula is C11H21N • HCI and its structural formula is:

Inversine (Mecamylamine HCI) Structural Formula Illustration

It is a white, odorless, or practically odorless, crystalline powder, is highly stable, soluble in water and has a molecular weight of 203.75.

INVERSINE (mecamylamine) is supplied as tablets for oral use, each containing 2.5 mg mecamylamine HCI. Inactive ingredients are acacia, calcium phosphate, D&C Yellow 10, FD&C Yellow 6, lactose, magnesium stearate, starch, and talc.

Last reviewed on RxList: 12/2/2008
This monograph has been modified to include the generic and brand name in many instances.

Inversine Patient Information Including Side Effects

Brand Names: Inversine

Generic Name: mecamylamine (Pronunciation: meck a MILL a meen)

What is mecamylamine (Inversine)?

Mecamylamine is used to treat moderate to severe hypertension (high blood pressure). Because of its many side effects, mecamylamine is not commonly used.

Mecamylamine may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of mecamylamine (Inversine)?

If you experience any of the following serious side effects, stop taking mecamylamine and seek emergency medical attention:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives); or
  • abdominal pain, abdominal distention, or diarrhea.

Other, less serious side effects may be more likely to occur. Continue to take mecamylamine and talk to your doctor if you experience

  • nausea, vomiting, or constipation;
  • dry mouth;
  • decreased appetite;
  • dizziness and fainting;
  • drowsiness or weakness;
  • dilated (large) pupils and blurred vision; or
  • difficulty urinating.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the Inversine (mecamylamine) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about mecamylamine (Inversine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Mecamylamine may cause dizziness. If you experience dizziness, avoid these activities.

If you experience dizziness, rise slowly from a sitting or lying position to avoid falling.

Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking mecamylamine.

Take mecamylamine every day at the same time, usually after meals.

Call your doctor if you experience tremor, abdominal pain, abdominal distention, or diarrhea.

Side Effects Centers

Inversine Patient Information including How Should I Take

Who should not take mecamylamine (Inversine)?

Before taking this medication, tell your doctor if you

  • have arteriosclerosis (poor blood flow in the arteries, or "hardening of the arteries") in your heart (coronary) or to the head (cerebral);
  • have recently had a heart attack;
  • have glaucoma;
  • have kidney disease; or
  • have difficulty urinating as a result of an enlarged prostate or some other cause.

You may not be able to take mecamylamine, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.

Mecamylamine is in the FDA pregnancy category C. This means that it is not known whether mecamylamine will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant.

It is not known whether mecamylamine passes into breast milk. Do not take mecamylamine without first talking to your doctor if you are breast-feeding a baby.

How should I take mecamylamine (Inversine)?

Take mecamylamine exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

Take mecamylamine after meals.

Take each dose at the same time every day.

Do not stop taking this medication unless your doctor approves. Not taking your medication could make your condition much worse.

Store mecamylamine at room temperature away from moisture and heat.

Side Effects Centers

Inversine Patient Information including If I Miss a Dose

What happens if I miss a dose (Inversine)?

Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose (Inversine)?

Seek emergency medical attention.

Symptoms of a mecamylamine overdose include fainting, dizziness, weakness, confusion, nausea, vomiting, diarrhea, constipation, difficulty urinating, anxiety, dry mouth, large pupils, blurred vision, and an irregular heartbeat.

What should I avoid while taking this mecamylamine (Inversine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Mecamylamine may cause dizziness. If you experience dizziness, avoid these activities.

If you experience dizziness, rise slowly from a sitting or lying position to avoid falling.

Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking mecamylamine.

What other drugs will affect mecamylamine (Inversine)?

Generally, mecamylamine should not be used during treatment with antibiotics or sulfa-based drugs. Tell your doctor if you are taking drugs of either of these types.

Other drugs used to lower high blood pressure may increase the effects of mecamylamine, and serious side effects could occur. Tell your doctor about all medicines you take to lower high blood pressure or to treat other heart conditions.

Anesthesia (use of drugs that put you to sleep for surgery) may also increase the effects of mecamylamine. Tell your doctor or dentist that you are taking mecamylamine before you have surgery.

Drugs other than those listed here may also interact with mecamylamine or affect your condition. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Where can I get more information?

Your pharmacist has additional information about mecamylamine written for health professionals that you may read.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.07. Revision date: 12/15/2010.

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