Sunday, July 29, 2012

Little Colds Multi-Symptom Drops


Pronunciation: a-seet-a-MIN-oh-fen/dex-troe-meth-OR-fan/fen-ill-EF-rin
Generic Name: Acetaminophen/Dextromethorphan/Phenylephrine
Brand Name: Little Colds Multi-Symptom


Little Colds Multi-Symptom Drops are used for:

Relieving pain, congestion, and cough due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.


Little Colds Multi-Symptom Drops are an analgesic, cough suppressant, and decongestant combination. The analgesic and cough suppressant work in the brain to decrease pain and reduce the cough reflex. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages, which helps you breathe more easily.


Do NOT use Little Colds Multi-Symptom Drops if:


  • you are allergic to any ingredient in Little Colds Multi-Symptom Drops

  • you have severe high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease)

  • you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.



Before using Little Colds Multi-Symptom Drops:


Some medical conditions may interact with Little Colds Multi-Symptom Drops. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have a history of glaucoma, an enlarged prostate gland or other prostate problems, heart problems, diabetes, high blood pressure, blood vessel problems, adrenal gland problems, an overactive thyroid, seizures, stroke, liver problems (eg, hepatitis), or severe kidney problems, or if you drink more than 3 alcohol-containing drinks per day

  • if you have a history of asthma, chronic cough, chronic obstructive pulmonary disease (COPD), or other lung problems (eg, chronic bronchitis, emphysema), or if your cough produces large amounts of mucus

Some MEDICINES MAY INTERACT with Little Colds Multi-Symptom Drops. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, isoniazid, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because the risk of side effects from Little Colds Multi-Symptom Drops may be increased

  • Anticoagulants (eg, warfarin), digoxin, or droxidopa because the risk of side effects such as bleeding, irregular heartbeat, or heart attack may be increased

  • Bromocriptine because the risk of side effects may be increased by Little Colds Multi-Symptom Drops

  • Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Little Colds Multi-Symptom Drops

This may not be a complete list of all interactions that may occur. Ask your health care provider if Little Colds Multi-Symptom Drops may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Little Colds Multi-Symptom Drops:


Use Little Colds Multi-Symptom Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Little Colds Multi-Symptom Drops may be taken with or without food.

  • Use the dropper that comes with Little Colds Multi-Symptom Drops to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.

  • If you miss a dose of Little Colds Multi-Symptom Drops, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Little Colds Multi-Symptom Drops.



Important safety information:


  • Little Colds Multi-Symptom Drops may cause dizziness or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Little Colds Multi-Symptom Drops. Using Little Colds Multi-Symptom Drops alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.

  • Do not take appetite suppressants while you are taking Little Colds Multi-Symptom Drops without checking with your doctor.

  • Little Colds Multi-Symptom Drops contains acetaminophen, dextromethorphan, and phenylephrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains acetaminophen, dextromethorphan, or phenylephrine. If it does or if you are uncertain, contact your doctor or pharmacist.

  • Do NOT exceed the recommended dose or take Little Colds Multi-Symptom Drops for longer than prescribed without checking with your doctor.

  • If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.

  • Little Colds Multi-Symptom Drops may cause liver damage. If you consume 3 or more alcohol-containing drinks every day, ask your doctor if you should take Little Colds Multi-Symptom Drops or other pain relievers/fever reducers. Alcohol use combined with Little Colds Multi-Symptom Drops may increase your risk for liver damage.

  • Little Colds Multi-Symptom Drops may interfere with certain lab test results. Make sure that all of your doctors and lab personnel know that you are taking Little Colds Multi-Symptom Drops.

  • Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Little Colds Multi-Symptom Drops.

  • Use Little Colds Multi-Symptom Drops with caution in the ELDERLY because they may be more sensitive to its effects.

  • Caution is advised when using Little Colds Multi-Symptom Drops in CHILDREN because they may be more sensitive to its effects.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Little Colds Multi-Symptom Drops, discuss with your doctor the benefits and risks of using Little Colds Multi-Symptom Drops during pregnancy. It is unknown if Little Colds Multi-Symptom Drops are excreted in breast milk. Do not breast-feed while taking Little Colds Multi-Symptom Drops.


Possible side effects of Little Colds Multi-Symptom Drops:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Dizziness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; stomach pain; tremor; yellowing of skin or eyes.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Little Colds Multi-Symptom side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; stomach pain; unusually fast, slow, or irregular heartbeat; vomiting; yellowing of skin or eyes.


Proper storage of Little Colds Multi-Symptom Drops:

Store Little Colds Multi-Symptom Drops at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Little Colds Multi-Symptom Drops out of the reach of children and away from pets.


General information:


  • If you have any questions about Little Colds Multi-Symptom Drops, please talk with your doctor, pharmacist, or other health care provider.

  • Little Colds Multi-Symptom Drops are to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Little Colds Multi-Symptom Drops. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Little Colds Multi-Symptom resources


  • Little Colds Multi-Symptom Side Effects (in more detail)
  • Little Colds Multi-Symptom Use in Pregnancy & Breastfeeding
  • Little Colds Multi-Symptom Drug Interactions
  • 0 Reviews for Little Colds Multi-Symptom - Add your own review/rating


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Saturday, July 28, 2012

Magnesium Sulfate



Class: Anticonvulsants, Miscellaneous
VA Class: CN400
CAS Number: 10034-99-8

Introduction

Anticonvulsant parenterally; electrolyte; required cofactor for numerous human enzyme systems.a h


Uses for Magnesium Sulfate


Prevention and Control of Seizures


Injection mainly used as an anticonvulsant for the prevention and control of seizures in toxemia (preeclampsia or eclampsia) of pregnancy, acute nephritis (in children), and in various other conditions.67


Toxemias of Pregnancy


Generally considered the anticonvulsant drug of choice for the prevention and control of seizures in severe preeclampsia or in eclampsia,58 59 60 61 and appears to be more effective than phenytoin.58 60 61 d


Opinions differ regarding the role for prophylactic use in preventing seizures in mild preeclampsia or gestational hypertension.d


Also used in the management of uterine tetany, especially that associated with the use of oxytocic agents.a


Acute Nephritis in Children


Has been used to control seizures, encephalopathy, and hypertension associated with acute nephritis in children.67 However, other agents (e.g., barbiturates, reserpine, hydralazine) should be tried first.67


Some clinicians caution not to use parenteral magnesium sulfate to control seizures unless hypomagnesemia has been confirmed, and to monitor serum magnesium concentration when administered.a


Reserve IV use for immediate control of life-threatening seizures.a


Other Seizure Etiologies


Parenterally, may be useful to control seizures associated with epilepsy, glomerulonephritis, or hypothyroidism, since low plasma concentrations of magnesium may be a contributing cause of seizures in these conditions.a


Prevention and Treatment of Hypomagnesemia


Injection is added to total parenteral nutrition admixtures to correct or prevent hypomagnesemia.67


Treatment of acute hypomagnesemia associated with clinical conditions including malabsorption syndromes, alcoholism, cirrhosis of the liver, acute pancreatitis, or prolonged IV therapy with magnesium-free fluids.a 70


Especially effective in the treatment of acute hypomagnesemia accompanied by signs of tetany similar to those of hypocalcemia;67 usually, serum magnesium concentrations are below the lower limits of normal (1.5–2.5 or 3 mEq/L), and serum calcium concentrations are either normal (4.3–5.3 mEq/L) or elevated in such cases.67


Preterm Labor


Has been used to inhibit uterine contractions in preterm labor (tocolysis) and prolong gestation when beneficial.13 14


Previously, the American College of Obstetricians and Gynecologists (ACOG) considered magnesium sulfate a first-line tocolytic agent of choice; currently, ACOG states that there is no clear first-line tocolytic agent.69


May be contraindicated by maternal or fetal conditions.13 (See Contraindications under Cautions.)


Following successful cessation of uterine contractions, oral maintenance therapy with other magnesium salts (e.g., oxide or gluconate) has not been consistently beneficial.13 20


Combination therapy with another tocolytic agent may be more effective than single-agent therapy, but may increase risk of maternal morbidity, and safety and efficacy have not been established; use with caution.13 19 24 25 27 69


Concurrent use of magnesium sulfate and nifedipine may be particularly risky (e.g., development of severe hypotension and neuromuscular blockade).13 32 69


Arrhythmias


Used IV successfully for the treatment of life-threatening arrhythmias such as atypical VT (torsades de pointes).h 8 9 10


Considered one of several preferred drugs in the treatment of polymorphic VT suspected of being torsades de pointes in patients in whom initial attempts at correcting or managing potential precipitating factors (e.g., ischemic cardiac events, electrolyte imbalance, drugs known to prolong the QT interval) have not been successful.h 64 66 70


Not recommended in the treatment of cardiac arrest except when the ECG monitoring shows torsades de pointes.70


Drug-induced cardiovascular emergencies or altered vital signs: May consider use in VT associated with tricyclic antidepressant toxicity; however, use may aggravate drug-induced hypotension.70 Anecdotal evidence suggests that magnesium sulfate also may be an effective treatment in antiarrhythmic drug-induced torsades de pointes even in the absence of magnesium deficiency.66 70


Has been used IV in the management of paroxysmal atrial tachycardia when other measures have failed and when there is no evidence of myocardial damage.a


May consider use in atrial fibrillation with a rapid ventricular response for rate control.70


AMI


Has been administered IV adjunctively to reduce cardiovascular morbidity and mortality (e.g., through reduction in ventricular arrhythmias and/or limitation of infarct size and reperfusion injury) associated with AMI;2 6 7 34 35 36 37 38 39 64 however, evidence of benefit is contradictory and the precise role remains unclear.34 44 45 46 47 64


Routine magnesium prophylaxis in AMI no longer recommended.64 70


Instead, ACC and AHA currently recommend that magnesium in AMI be reserved for patients with documented magnesium and/or potassium deficits, especially in patients receiving diuretics prior to infarction.64


ACC/AHA state that it is sound clinical practice to maintain magnesium concentrations >2 mEq/L in patients with AMI.64 66 70


Recommended by ACC/AHA in AMI for episodes of torsades de pointes-type VT.64 66


Recommended by ACC/AHA for consideration in high-risk patients such as geriatric patients and/or those for whom reperfusion therapy is not suitable.


ACC/AHA state that mortality reduction may be possible with magnesium use in certain high-risk patients with AMI (e.g., geriatric patients, those who are not eligible for reperfusion therapy) if they receive the drug as soon as possible after symptom onset (within 6 hours); however, conflicting evidence and/or divergence of opinion about usefulness/efficacy.64 66


Acute Asthma


May modestly improve pulmonary function and reduce hospital admissions when combined with nebulized β-adrenergic agents and corticosteroids, particularly in patients with severe exacerbations of asthma.70


Barium Poisoning


Administered IV to counteract the intense muscle stimulating effects of barium poisoning.


Also may administer by gastric lavage or oral solution to precipitate and remove unabsorbed barium.a (See Dosage under Dosage and Administration.)


Magnesium Sulfate Dosage and Administration


Administration


Administer IV or IM.a 70


For ACLS during CPR, may be administered by intraosseous infusion when IV injection is not possible.70


IV Administration


Generally, concentration should not be >200 mg/mL (20%).a


Rate of Administration

Risk of vasodilation or hypotension if administered rapidly.70


Usually, do not exceed 150 mg/minute (e.g., 1.5 mL/minute of a 10% concentration or equivalent) except in patients with seizures associated with severe eclampsia (e.g., up to 1.33 g/minute for loading dose), preterm labor (e.g., 300 mg/minute for loading dose), or arrhythmias (e.g., 1–6 g over several minutes; 3–4 g over 30 seconds with extreme caution).67


IM Administration


Generally, use concentrations of 250 mg/mL (25%) or 500 mg/mL (50%).a


Infants and children: Usually, use concentration ≤200 mg/mL (20%).a However, higher concentrations (e.g., 50%) have been used.a c


Intraosseous Administration


When IV administration is not possible, magnesium sulfate may be given by intraosseous infusion for CPR.70


Dosage


Adjust dosage carefully according to individual requirements and response; discontinue as soon as the desired effect is obtained.a


Pediatric Patients


PALS in CPR

Torsades de Pointes or Suspected Hypomagnesemia

IV or Intraosseous

Infuse 25–50 mg/kg (up to 2 g) over 10–20 minutes.70


Infuse more rapidly (over several minutes) in torsades de pointes.70


Prevention and Control of Seizures

Acute Nephritis in Children

IM

To control seizures, encephalopathy, and hypertension: 100 mg/kg (0.8 mEq/kg or 0.2 mL/kg of a 50% solution) every 4–6 hours as needed.a


Alternatively to control seizures: 20–40 mg/kg (0.16–0.32 mEq/kg or 0.1–0.2 mL/kg of a 20% solution) as needed.67


IV

If symptoms are severe, may administer a 1–3% solution in a dosage of 100–200 mg/kg.a


Administer slowly; closely monitor BP.a


Administer total dose within 1 hour, with ½ the dose administered in the first 15–20 minutes.a


Hypomagnesemia

Prevention

Additive in Total Parenteral Infusion

Infants: Usually, 0.25–0.6 mEq/kg daily.67


Maintenance requirements not precisely known.67


Treatment

IM

Older children: For deficiency that is not severe, manufacturers recommend 1 g (2 mL of 50% solution) once or twice daily; use serum magnesium values as guide to continued dosage.c


Adults


Prevention and Control of Seizures

Toxemias of Pregnancy

For the management of preeclampsia or eclampsia, dilute (1–8%) solutions are often given by IV infusion in combination with IM injections using 50% magnesium sulfate.68


IV with IM

Severe preeclampsia or eclampsia: Initially, IV infusion of 4–5 g (32.4–40.5 mEq) diluted in 250 mL of 5% dextrose injection or 0.9% sodium chloride injection, in combination with IM injection of up to 10 g (10 mL of undiluted 50% solution administered into each buttock).67 Alternatively, after the initial 4- to 5-g IV dose, constant IV infusion of 1–3 g/hour has been recommended.a Total initial dose: 10–14 g (81–113.4 mEq).67 68


Alternatively, 8–15 g IV initially, depending on weight (8 g for a 45-kg patient to 15 g for a 90-kg patient); 4 g (undiluted or diluted in 5% dextrose injection); give remainder of initial dose IM using undiluted 50% injection.a Base dosage for the next 24 hours on the serum magnesium concentration and urinary excretion after the initial dose.a Subsequent doses should be sufficient to replace the magnesium excreted in the urine and will be approximately 65% of the initial dose administered IM at 6-hour intervals.a


Alternatively, the manufacturer recommends that an initial dose of 4 g (32.4 mEq) be given IV by diluting the 50% solution to 10 or 20% concentration; may then inject 40 mL of a 10% solution or 20 mL of a 20% solution IV over 3–4 minutes.67 Administer subsequent 4- to 5-g doses (32.4–40.5 mEq or 8–10 mL of the undiluted 50% injection) IM into alternate buttocks every 4 hours as needed, depending on the continuing presence of the patellar reflex and adequate respiratory function.67


Continue therapy until paroxysms cease.67


Serum magnesium concentration of 6 mg/dL is considered optimal for seizure control.67


IV

For eclampsia, ACOG currently recommends 4–6 g in 100 mL of IV fluid over 15–20 minutes, followed by 2 g per hour continuous IV infusion; use antihypertensive agents for women with DBP ≥105–110 mm Hg.d


Other Seizure Etiologies

IM or IV

For seizures associated with epilepsy, glomerulonephritis, or hypothyroidism: Usually, 1 g.a


Hypomagnesemia

Prevention

IV Infusion

Additive in total parenteral nutrition: Usually, 5–8 mEq daily.67


Maintenance requirements are not precisely known.67


Treatment

Use caution to prevent exceeding the renal excretory capacity.a


IM

Mild deficiency: Usually, 1 g (8.12 mEq or 2 mL of the 50% solution) every 6 hours for 4 doses.67


Alternatively, for deficiency that is not severe, 1 g (2 mL of 50% solution) once or twice daily; use serum magnesium concentrations as guide to continued dosage.c


Severe deficiency: If necessary, may administer up to 250 mg (about 2 mEq or 0.5 mL of the 50% solution) per kg of body weight within a 4-hour period.a f


Alternatively, for severe hypomagnesemia: 1–5 g (2–10 mL of 50% solution) daily in divided doses; repeat daily until serum levels are normal.c


Oral

For mild deficiency: 3 g every 6 hours for 4 doses.a


IV infusion

For severe deficiency: 5 g (approximately 40 mEq) added to 1 L of 5% dextrose injection or 0.9% sodium chloride injection over 3 hours.67 f


Alternatively, for severe or symptomatic hypomagnesemia, 1–2 g over 5–60 minutes.70 If seizures are present, administer 2 g over 10 minutes.70


Preterm Labor

Carefully adjust rate and duration of infusion according to the patient’s response as indicated (by uterine response, maternal and fetal tolerance).13 14 15 16 17 18


Monitoring of serum magnesium concentrations may be useful to minimize the risk of toxicity (e.g., respiratory depression, cardiotoxicity, maternal tetany, muscular paralysis, hypotension) and to determine the maximum safe infusion rate.13 33


Monitor amount and rate of IV fluid administration to avoid circulatory overload.13


Observe for signs and symptoms of pulmonary edema.13


IV Infusion

Acute tocolytic therapy: Loading dose of 4–6 g over 20 minutes; after contractions cease, follow with maintenance infusions of 2–4 g/hour for 12–24 hours as tolerated.13 14 15 16 17 18 e


Arrhythmias

Atypical VT (Torsades de Pointes)

IV

1–6 g over several minutes, occasionally followed by approximately 3–20 mg/minute by IV infusion for 5–48 hours, depending on response and serum magnesium concentrations.8 9 10 64


Alternatively, for torsades de pointes associated with cardiac (pulseless) arrest, 1–2 g in 10 mL 5% dextrose injection over 5–20 minutes.70


Alternatively, for torsades de pointes in a patient with pulses, give a loading dose of 1–2 g (8–16 mEq) in 50–100 mL 5% dextrose injection over 5–60 minutes.70


Intraosseous

Torsades de pointes associated with cardiac (pulseless) arrest: 1–2 g in 10 mL 5% dextrose injection over 5–20 minutes.70


Paroxysmal Atrial Tachycardia

IV

Usually, 3–4 g (e.g., 30–40 mL of a 10% solution) over 30 seconds with extreme caution.


AMI

IV

Optimum dosage not established.


2-g over 5–15 minutes, followed by 18 g over 24 hours (approximately 12.5 mg/minute).64


Timing appears to be an important prognostic factor;34 56 57 64 initiate administration as soon as possible (preferably no later than 6 hours) after symptom onset.64


Acute Asthma

IV

Usually, 1.2–2 g over 20 minutes.70


Barium Poisoning

IV

Usually, 1–2 g to counteract the intense muscle stimulating effects of barium.a


Gastric Lavage or Oral

May administer 2–5% magnesium sulfate (or sodium sulfate) solution by gastric lavage to precipitate and remove unabsorbed barium remaining in the GI tract.a


Alternatively, may administer 5–10% magnesium sulfate (or sodium sulfate) solution (up to 60 g) orally to precipitate barium and produce catharsis.a


Prescribing Limits


Pediatric Patients


PALS in CPR

Torsades de Pointes or Suspected Hypomagnesemia

IV or Intraosseous

Maximum 2 g, as a single dose.70


Adults


Prevention and Control of Seizures

Toxemias of Pregnancy

IV with IM

Do not exceed total daily dosage of 30–40 g.a


Special Populations


Renal Impairment


Prevention and Control of Seizures

Toxemias of Pregnancy

IV with IM

Maximum 20 g/48 hours in severe renal impairment.a


Geriatric Patients


Often require reduced dosage because of impaired renal function.f Maximum 20 g/48 hours in severe renal impairment.f


Cautions for Magnesium Sulfate


Contraindications



  • Parenteral administration in heart block or myocardial damage.a c




  • Tocolytic therapy in general may be contraindicated by some maternal or fetal conditions (e.g., acute fetal distress other than intrauterine resuscitation, chorioamnionitis, fetal demise [singleton], fetal maturity, maternal hemodynamic instability).13




  • Tocolytic therapy may be contraindicated by hypocalcemia, myasthenia gravis, renal failure.13




  • In toxemia of pregnancy during 2 hours prior to delivery.67 68



Warnings/Precautions


Warnings


Toxicity

Principal hazard is hypermagnesemia, most immediate life-threatening effect is respiratory depression; have IV calcium (e.g., calcium gluconate) readily available for use as antidote.a c 70


Adverse effects of parenteral therapy are caused by magnesium intoxication.a


Toxic manifestations (may begin at serum magnesium concentrations of 4 mEq/L) include neurologic symptoms (e.g., muscular weakness, flaccid paralysis, ataxia, drowsiness, confusion, depression of reflexes), flushing, sweating, vasodilation, hypotension, hypothermia, depression of cardiac function, bradycardia, cardiac arrhythmias, circulatory collapse, hypoventilation, and CNS depression (depressed level of consciousness); can proceed to fatal respiratory paralysis.a 70


Observe carefully, and monitor serum magnesium concentrations to avoid overdosage and toxicity.a


During tocolytic therapy, observe carefully and monitor serum magnesium concentrations to minimize the risk of toxicity (e.g., respiratory depression, cardiotoxicity, maternal tetany, muscular paralysis, hypotension).13 21 22 23


Hypocalcemia with signs of tetany can occur during tocolytic use.a


Patellar reflex disappearance is useful to detect intoxication onset.a Test knee jerk reflexes before each dose; if absent, give no additional magnesium until they return.a


Make sure respiration rate is ≥16/minute prior to each dose.a


Do not continue dosage unless urine output is 100 mL or more during the 4 hours preceding each dose.a


If overdosage occurs, provide artificial ventilation until a calcium salt can be given IV.a


In adults, IV administration of 5–10 mEq of calcium (e.g., 10–20 mL of 10% calcium gluconate) usually will reverse respiratory depression or heart block caused by magnesium intoxication.a


Peritoneal dialysis or hemodialysis may be required in extreme cases of hypermagnesemia.a


Maternal Pulmonary Edema

Risk of maternal pulmonary edema with tocolytic therapy; development during the initial 24 hours is uncommon.13


Etiology is unclear;13 risk factors include excessive hydration, multiple gestation, occult sepsis, and underlying cardiac disease.13


Adjunctive corticosteroid therapy apparently is not an important risk factor .13


Reduce risk by limiting fluid intake to 2.5–3 L daily, limiting sodium intake, and maintaining maternal pulse <130 bpm.13


Monitor amount and rate of IV fluid administration to avoid circulatory overload; observe carefully for signs/symptoms of pulmonary edema.13


Hypocalcemia

Clinically important hypocalcemia with signs of tetany has occurred after use for eclampsia.a Changes in calcium and phosphorus balance should be anticipated in each case of parenteral magnesium administration.a


Major Toxicities


Respiratory Depression

See Warnings under Cautions.


General Precautions


Use with caution if flushing and sweating occur.c


CNS Depressants

Adjust dosage carefully with concomitant use; have IV calcium (e.g., calcium gluconate) readily available for use as antidote for magnesium toxicity.a c (See CNS Depressants under Interactions.)


Laboratory Tests

Confirm hypomagnesemia, monitor serum magnesium concentration.c (See Warnings under Cautions.)


Specific Populations


Pregnancy

Category A or B.67 68 f


Although one manufacturer states category D and that parenteral magnesium may cause fetal harm in pregnant women or those becoming pregnant during use,c most experts consider the drug category B and state that maternal anticonvulsant or tocolytic use usually does not pose fetal or neonatal risk except with prolonged IV infusions.b


Increased possibility of neonatal toxicity (including neuromuscular or respiratory depression) with prolonged continuous IV infusion before delivery (especially for >24 hours); IM use does not usually compromise neonate.a b


Do not give IV during the 2 hours preceding delivery.a


Neonatal hypermagnesemia management may require resuscitation and assisted ventilation via endotracheal intubation and/or intermittent positive-pressure ventilation, as well as IV calcium.a


Lactation

Distributed into milk.a b Caution if used in nursing women,a but generally considered compatible with breast-feeding.b


Milk magnesium concentrations increased for only about 24 hours after discontinuance of parenteral magnesium; amount ingested by a nursing infant during this period is probably too small to be of clinical importance.a b


Pediatric Use

Although one manufacturer states safety and efficacy not established in children,c other manufacturers make no pediatric restrictions.67 68 f g


Included in current CPR guidelines for pediatric advanced life support (PALS).70 64


Geriatric Use

Often requires reduced dosage because of impaired renal function.f (See Geriatric Use under Dosage and Administration.)


Renal Impairment

Administer with caution in renal impairment; danger of magnesium intoxication.a c f


Reduce dosage and obtain frequent serum magnesium concentrations in severe renal impairment.a (See Renal Impairment under Dosage and Administration.)a


Common Adverse Effects


Flushing, sweating, hypotension, depression of reflexes, flaccid paralysis, hypothermia, circulatory collapse, depression of cardiac function, CNS depression.a


Interactions for Magnesium Sulfate


Specific Drugs


















Drug



Interaction



Comments



CNS depressants (e.g., barbiturates, opiates, general anesthetics)



Additive central depressant effects with concomitant usea



Adjust dosage carefullya


Have IV calcium (e.g., calcium gluconate) preparation readily available for use as antidotec



Digoxin



Serious changes in cardiac conduction; may cause heart block if IV calcium is required to treat magnesium toxicitya



Use with extreme caution in digitalized patientsa



Neuromuscular blocking agents



Excessive neuromuscular blockade a



Use concomitantly with cautiona


Magnesium Sulfate Pharmacokinetics


Absorption


Onset


IV administration: Immediate onset.a


IM administration: About 1 hour.a


Duration


IV administration: About 30 minutes.a


IM administration: 3–4 hours.a


Plasma Concentrations


Effective anticonvulsant serum magnesium concentrations: 2.5–7.5 mEq/L.a


Monitor for hypermagnesemia (serum concentrations >2.5 mEq/L); toxic effects (e.g., depression of deep-tendon reflexes) may begin at 4 mEq/L.a


At 10 mEq/L, deep-tendon reflexes disappear and respiratory paralysis may occur; complete heart block can occur at about 10 mEq/L.a


Serum magnesium >12 mEq/L may be fatal.


Distribution


Extent


Crosses the placenta.a b


Distributes into milk.a b


Elimination


Elimination Route


Excreted by the kidneys; interindividual variability in rate but directly proportional to serum concentration and glomerular filtration.a h


Stability


Storage


Parenteral


Injection

15–30°C.67 f g


Magnesium Sulfate in 5% Dextrose Injection

25°C (may expose to up to 40°C).67 Avoid freezing.a


Compatibility


For information on systemic interactions resulting from concomitant use, see Interactions.


Incompatible with alkali hydroxides (forming insoluble magnesium hydroxide), with alkali carbonates (forming basic carbonates), and with salicylates (forming basic salicylates).a


Reacts with arsenates, phosphates, and tartrates, precipitating the corresponding magnesium salts.a


Lead, barium, strontium, and calcium react with magnesium sulfate resulting in precipitation of the respective sulfates.a


Parenteral


Solution CompatibilityHID








Compatible



Dextrose 5% in water



Ringer’s injection, lactated



Sodium chloride 0.9%



Incompatible



Fat emulsion 10%, IV


Drug Compatibility


























Admixture CompatibilityHID

Compatible



Chloramphenicol sodium succinate



Cisplatin



Heparin sodium



Hydrocortisone sodium succinate



Isoproterenol HCl



Linezolid



Meropenem



Methyldopate HCl



Norepinephrine bitartrate



Penicillin G potassium



Potassium chloride



Potassium phosphates



Verapamil HCl



Incompatible



Amphotericin B



Cyclosporine



Dobutamine HCl



Polymyxin B sulfate



Procaine HCl



Sodium bicarbonate



Variable



Calcium chloride



Calcium gluconate





































































Y-Site CompatibilityHID

Compatible



Acyclovir sodium



Aldesleukin



Amifostine



Amikacin sulfate



Ampicillin sodium



Aztreonam



Bivalirudin



Cefazolin sodium



Cefotaxime sodium



Cefoxitin sodium



Chloramphenicol sodium succinate



Clindamycin phosphate



Co-trimoxazole



Dexmedetomidine HCl



Dobutamine HCl



Docetaxel



Doxorubicin HCl liposome injection



Doxycycline hyclate



Enalaprilat



Erythromycin lactobionate



Esmolol HCl



Etoposide phosphate



Famotidine



Fenoldopam mesylate



Fludarabine phosphate



Gallium nitrate



Gentamicin sulfate



Granisetron HCl



Heparin sodium



Hetastarch in lactated electrolyte injection (Hextend)



Hydrocortisone sodium succinate



Hydromorphone HCl



Idarubicin HCl



Kanamycin sulfate



Labetalol HCl



Linezolid



Meperidine HCl



Metronidazole



Milrinone lactate



Morphine sulfate



Nafcillin sodium



Nicardipine HCl



Ondansetron HCl



Oxacillin sodium



Oxaliplatin



Paclitaxel



Penicillin G potassium



Piperacillin sodium–tazobactam sodium



Potassium chloride



Propofol



Remifentanil HCl



Sargramostim



Sodium nitroprusside



Thiotepa



Tobramycin sulfate



Vancomycin HCl



Vitamin B complex with C



Incompatible



Amphotericin B cholesteryl sulfate complex



Cefepime HCl



Drotrecogin alfa (activated)



Lansoprazole



Variable



Amiodarone



Ciprofloxacin


ActionsActions



  • Hypermagnesemia (serum magnesium concentrations >2.5 mEq/L) may depress the CNS and block peripheral neuromuscular transmission, producing anticonvulsant effects.a




  • Exact mechanism is not fully known; excess magnesium appears to decrease the amount of acetylcholine liberated by the motor nerve impulse.a




  • Magnesium ions slow the rate of the SA node impulse formation and prolong conduction time in animals.a




  • IV infusion prolongs PR interval, H (atria-His bundle) interval, antegrade AV nodal effective refractory period, and SA conduction time in humans.a




  • Required cofactor for >300 enzyme systems.h




  • Required for both anaerobic and aerobic energy generation and for glycolysis.h




  • Described as nature’s physiologic calcium-channel blocking agent.h




  • During magnesium depletion, intracellular calcium increases, which can cause muscle cramps, hypertension, and coronary and cerebral vasospasms.h




  • Plays an important role in BP regulation; hypertension may be associated with magnesium deficiency and magnesium may decrease BP in hypertension.h




  • Important role in bone and mineral homeostasis and can directly affect bone cell formation and influence hydroxyapatite crystal formation and growth; deficiency may be risk factor for osteoporosis.h




  • Insulin resistance and impaired insulin secretion with deficiency.h



Advice to Patients



  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.a




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.a




  • Importance of informing patients of other important precautionary information. (See Cautions.)



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.


* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name




























Magnesium Sulfate

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Bulk



Crystals



Parenteral



Injection



50%*



Magnesium Sulfate Injection



Abraxis, American Regent, Hospira, IMS



Injection, for IV use only



4% (4, 20, and 40 g)



Magnesium Sulfate Injection



Hospira



8% (4 g)



Magnesium Sulfate Injection



Hospira













Magnesium Sulfate in Dextrose

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Parenteral



Injection, for IV use only



1% (1 g) in 5% Dextrose



Magnesium Sulfate in 5% Dextrose Injection



Hospira



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions January 2010. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.


† Use is not currently included in the labeling approved by the US Food and Drug Administration.




References



2. Abraham AS, Rosenmann D, Kramer M et al. Magnesium in the prevention of lethal arrhythmias in acute myocardial infarction. Arch Intern Med. 1987; 147:753-5. [IDIS 227956] [PubMed 3548627]



6. Rasmussen HS, Norregard P, McNair P et al. Intravenous magnesium in acute myocardial infarction. Lancet. 1986; 1:234-6. [IDIS 210464] [PubMed 2868254]



7. Rasmussen HS, Grnbaek M, Cintin C et al. One-year death rate in 270 patients with suspected acute myocardial infarction, initially treated with intravenous magnesium or placebo. Clin Cardiol. 1988; 11:377-81. [PubMed 3396238]



8. Allen BJ, Brodsky MA, Capparelli EV et al. Magnesium sulfate therapy for sustained monomorphic ventricular tachycardia. Am J Cardiol. 1989; 64:1202-4. [IDIS 305714] [PubMed 2816773]



9. Banai S et al. Magnesium sulfate is the treatment of choice for torsades de pointes if the right dose is given. Am J Cardiol. 1989; 65:266.



10. Tzivoni D, Banai S, Schuger C et al. Treatment of torsade de pointes with magnesium sulfate. Circulation. 1988; 79:392-7.



11. Skobeloff EM, Spivey WH, McNamara RM et al. Intravenous magnesium sulfate for the treatment of acute asthma in the emergency department. JAMA. 1989; 262:1210-3. [IDIS 258000] [PubMed 2761061]



12. Okayama H, Aikawa T, Okayama M et al. Bronchodilating effect of intravenous magnesium sulfate in bronchial asthma. JAMA. 1987; 257:1076-8. [IDIS 225846] [PubMed 3806898]



13. American College of Obstetricians and Gynecologists (AGOG) Committee on Technical Bulletins. Preterm labor. Technical Bulletin No. 206. Washington, DC: American College of Obstetricians and Gynecologists; 1995 Jun:1-10.



14. Morales WJ, Madhav H. Efficacy and safety of indomethacin compared with magnesium sulfate in the management of preterm labor: a randomized study. Am J Obstet Gynecol. 1993; 169:97-102. [IDIS 318916] [PubMed 8333483]



15. Glock JL, Morales WJ. Efficacy and safety of nifedipine versus magnesium sulfate in the management of preterm labor: a randomized study. Am J Obstet Gynecol. 1993; 169:960-4. [IDIS 321360] [PubMed 8238157]



16. Beall MH, Edgar BW, Paul RH et al. A comparison of ritodrine, terbutaline, and magnesium sulfate for the suppression of preterm labor. Am J Obstet Gynecol. 1985; 153:854-9. [IDIS 211026] [PubMed 4073155]



17. Hollander DI, Nagey DA, Pupkin MJ. Magnesium sulfate and ritodrine hydrochloride: a randomized comparison. Am J Obstet Gynecol. 1987; 156:631-7. [IDIS 227015] [PubMed 3548382]



18. Wilkins IA, Lynch L, Mehalek KE et al. Efficacy and side effects of magnesium sulfate and ritodrine as tocolytic agents. Am J Obstet Gynecol. 1988; 159:685-9. [IDIS 246807] [PubMed 3048103]



19. Lewis DF, Grimshaw A, Brooks GG et al. A comparison of magnesium sulfate and indomethacin to magnesium sulfate only for tocolysis in preterm labor with advanced cervical dilation. Southern Med J. 1995; 88:737-40. [PubMed 7597478]



20. Travis BE, McCullough JM. Pharmacotherapy of preterm labor. Pharmacotherapy. 1993; 13:28-36. [IDIS 311789] [PubMed 8437965]



21. Cox SM, Sherman ML, Leveno KJ. Randomized investigation of magnesium sulfate for prevention of preterm birth. Am J Obstet Gynecol. 1990; 163:767-72. [IDIS 272666] [PubMed 2206069]



22. Elliott JP. Subtherapeutic doses of magnesium sulfate do not inhibit preterm labor. Am J Obstet Gynecol. 1992; 167:568. [IDIS 301174] [PubMed 1497070]



23. Madden C, Owen J, Hauth JC. Magnesium tocolysis: serum levels versus success. Am J Obstet Gynecol. 1990; 162:1177-80. [IDIS 301277] [PubMed 2339717]



24. Kosasa TS, Busse R, Wahl N et al. Long-term tocolysis with combined intravenous terbutaline and magnesium sulfate: a 10-year study of 1000 patients. Obstet Gynecol. 1994; 84:369-73. [IDIS 33

Incretin mimetics


A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Incretin mimetics are agents that act like incretin hormones such as glucagon-like peptide-1 (GLP-1). They bind to GLP-1 receptors and stimulate glucose dependent insulin release, therefore act as antihyperglycemics.


Incretin mimetics also suppress appetite and inhibit glucagon secretion. They slow gastric emptying and as a result prevent steep rise in post-prandial blood glucose levels.


Incretin mimetics are only used to treat type 2 diabetes.

See also

Medical conditions associated with incretin mimetics:

  • Diabetes, Type 1
  • Diabetes, Type 2
  • Obesity

Drug List:

Thursday, July 26, 2012

Vitamin/Mineral Supplementation during Pregnancy/Lactation Medications


Drugs associated with Vitamin/Mineral Supplementation during Pregnancy/Lactation

The following drugs and medications are in some way related to, or used in the treatment of Vitamin/Mineral Supplementation during Pregnancy/Lactation. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.





Drug List:

Methscopolamine





Dosage Form: tablet
Methscopolamine Bromide Tablets USP

Rx Only



DESCRIPTION


Methscopolamine Bromide Tablets USP, 2.5 mg and 5 mg contain Methscopolamine bromide, an anticholinergic, which occurs as white crystals, or as a white odorless crystalline powder. Methscopolamine bromide melts at about 225°C with decomposition. The drug is freely soluble in water, slightly soluble in alcohol, and insoluble in acetone and in chloroform.


The chemical name for Methscopolamine bromide is 3-Oxa–9–azoniatricyclo [3.3.1.02,4] nonane,7-(3-hydroxy-1-oxo-2-phenyl-propoxy)-9,9-dimethyl-, bromide, [7(S)-(1α, 2β,4β, 5α,7β)]-and the molecular weight is 398.30.


The structural formula is represented below:



Methscopolamine Bromide Tablets USP, 2.5 mg for oral administration contain 2.5 mg of Methscopolamine bromide.


Methscopolamine Bromide Tablets USP, 5 mg for oral administration contain 5 mg of Methscopolamine bromide.


Inactive ingredients: microcrystalline cellulose, pregelatinized starch, magnesium stearate.


Contains no lactose.



CLINICAL PHARMACOLOGY


Methscopolamine bromide is an anticholinergic agent which possesses most of the pharmacological actions of that drug class. These include reduction in volume and total acid content of gastric secretion, inhibition of gastrointestinal motility, inhibition of salivary excretion, dilation of the pupil and inhibition of accommodation with resulting blurring of vision. Large doses may result in tachycardia.


PHARMACOKINETICS


Methscopolamine bromide is quaternary ammonium derivative of scopolamine. As a class, these agents are poorly and unreliably absorbed.1,2 Total absorption of quaternary ammonium derivatives of the alkaloids is 10-25%. Rate of absorption is not available. Quaternary ammonium salts have limited absorption from intact skin, and conjunctival penetration is poor.1 Little is known of the fate and excretion of most of these agents.1 Following oral administration, drug effects appear in about one hour and persist for 4 to 6 hours.2 Methscopolamine bromide has limited ability to cross the blood-brain-barrier.3,4,5 The drug is excreted primarily in the urine and bile, or as unabsorbed drug in feces.2 There is no data on the presence of Methscopolamine in breast milk; traces of atropine have been found after administration of atropine.1



INDICATIONS AND USAGE


Adjunctive therapy for the treatment of peptic ulcer.


Methscopolamine BROMIDE HAS NOT BEEN SHOWN TO BE EFFECTIVE IN CONTRIBUTING TO THE HEALING OF PEPTIC ULCER, DECREASING THE RATE OF RECURRENCE OR PREVENTING COMPLICATIONS.



CONTRAINDICATIONS


Glaucoma; obstructive uropathy (e.g., bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (e.g., pyloroduodenal stenosis); paralytic ileus; intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis. Methscopolamine Bromide Tablets USP, 2.5 mg and 5 mg are contraindicated in patients who are hypersensitive to Methscopolamine bromide or related drugs.



WARNINGS


In the presence of high environmental temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with drug use. Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance treatment with this drug would be inappropriate and possibly harmful. Methscopolamine bromide may produce drowsiness or blurred vision. The patient should be cautioned regarding activities requiring mental alertness such as operating a motor vehicle or other machinery or performing hazardous work while taking this drug. With overdosage, a curare-like action may occur, i.e., neuromuscular blockade leading to muscular weakness and possible paralysis.



PRECAUTIONS


1. General precautions

Use Methscopolamine Bromide Tablets USP, 2.5 mg and 5 mg with caution in the elderly and in all patients with: autonomic neuropathy; hepatic or renal disease; or ulcerative colitis-large doses may suppress intestinal motility to the point of producing a paralytic ileus and for this reason precipitate or aggravate “toxic megacolon,” a serious complication of the disease.


The drug also should be used with caution in patients having hyperthyroidism, coronary heart disease, congestive heart failure, tachyrhythmia, tachycardia, hypertension, or prostatic hypertrophy.


2.  Information for patient

See statement under WARNINGS.


3.  Laboratory tests

Progress of the peptic ulcer under treatment should be followed by upper gastrointestinal contrast radiology or endoscopy to insure healing. Stool tests for occult blood and blood hemoglobin or hematocrit values should be followed to rule out bleeding from the ulcer.


4.  Drug interactions

Additive anticholinergic effects may result from concomitant use with antipsychotics, tricyclic antidepressants, and other drugs with anticholinergic effects. Concomitant administration with antacids may interfere with the absorption of Methscopolamine bromide.


5.  Carcinogenesis, mutagenesis, impairment of fertility

No long-term studies in animals have been performed to evaluate carcinogenic potential.


6.  Pregnancy Teratogenic Effects

Pregnancy Category C.

Animal reproduction studies have not been conducted with Methscopolamine bromide. It is also not known whether Methscopolamine bromide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Methscopolamine bromide should be given to a pregnant woman only if clearly needed.


7.  Nursing mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Methscopolamine bromide is administered to a nursing woman.


Anticholinergic drugs may suppress lactation.


8.  Pediatric use

Safety and efficacy in children have not been established.



ADVERSE REACTIONS


The following adverse reactions have been observed, but there is not enough data to support an estimate of frequency.

Cardiovascular: Tachycardia, palpitation.

Allergic: Severe allergic reaction or drug idiosyncrasies including anaphylaxis.

CNS: Headaches, nervousness, mental confusion, drowsiness, dizziness.

Special Senses: Blurred vision, dilatation of the pupil, cycloplegia, increased ocular tension, loss of taste.

Renal: Urinary hesitancy and retention.

Gastrointestinal: Nausea, vomiting, constipation, bloated feeling.

Dermatologic: Decreased sweating, urticaria and other dermal manifestations.

Miscellaneous: Xerostomia, weakness, insomnia, impotence, suppression of lactation.



DRUG ABUSE AND DEPENDENCE


Not applicable.



OVERDOSAGE


The symptoms of overdosage with Methscopolamine Bromide Tablets USP, 2.5 mg and 5 mg progress from intensification of the usual side effects to CNS disturbances (from restlessness and excitement to psychotic behavior), circulatory changes (flushing, fall in blood pressure, circulatory failure), respiratory failure, paralysis and coma.


Measures to be taken are (1) induction of emesis and (2) injection of physostigmine 0.5 to 2 mg intravenously, and repeated as necessary up to a total of 5 mg. Fever may be treated symptomatically (alcohol sponging, ice packs). Excitement of a degree which demands attention may be managed with sodium thiopental 2% solution given slowly intravenously or chloral hydrate (100-200 mL of a 2% solution) by rectal infusion. In the event of progression of the curare-like effect to paralysis of the respiratory muscles, artificial respiration should be instituted and maintained until effective respiratory action returns.


The oral LD50 in rats is 1,352 to 2,617 mg/ kg. No data is available on the dialyzability of Methscopolamine bromide.



DOSAGE AND ADMINISTRATION


The average dosage of Methscopolamine Bromide Tablets USP is 2.5 mg one-half hour before meals and 2.5 to 5 mg at bedtime. A starting dose of 12.5 mg daily will be clinically effective in most patients without the production of appreciable side effects.


If the patient is having severe symptoms which demand prompt relief, the drug may be started on a daily dosage of 20 mg, administered in doses of 5 mg one-half hour before meals and at bedtime. If very unpleasant side effects develop promptly, the daily dosage should be reduced. If neither symptomatic relief nor side effects appear, the daily dosage may be increased. Some patients have tolerated 30 mg daily with no unpleasant reactions.


Patients whose dosage has been reduced to eliminate or modify side effects often continue to show adequate response both subjectively in relief of symptoms and objectively as measured by antisecretory effects.


The ultimate aim of therapy is to arrive at a dosage which provides maximal clinical effectiveness with a minimum of unpleasant side effects. Many patients report no side effects on a dosage which gives complete relief of symptoms. On the other hand, some patients have reported severe side effects without appreciable symptomatic relief. Such patients must be considered unsuited for this therapy. Usually they have been or will prove to be similarly intolerant to other anticholinergic drugs. If Methscopolamine bromide is to be used in a patient who gives a history of such intolerance, it should be started at a low dosage.



HOW SUPPLIED


Methscopolamine Bromide Tablets USP, 2.5 mg tablets are available as white, round tablets, debossed with “BOCA” on one side, debossed “603” on opposite:

Bottles of 100 (NDC 64376-603-01)


Methscopolamine Bromide Tablets USP, 5 mg are available as white, oval-shaped tablets, debossed with “BOCA” on one side, debossed “604” on opposite:

Bottles of 60 (NDC 64376-604-61)


Store at 20°-25°C (68°-77°F) (See USP Controlled Room Temperature).


KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.



REFERENCES


1. The Pharmacological Basis of Therapeutics, Gilman and Goodman, MacMillan Publ. Co., New York, 6th Ed., 1980.

2. American Hospital Formulary Service, American Society of Hospital Pharmacists, Bethesda, Maryland.

3. Domino, E.F., Corasen, G.: Central and Peripheral Effects of Muscarinic Cholinergic Blocking Agents in Man. Anesthesiology 28:568-574 (1967).

4. Mogensen, L. and Orinius, E.: Arrhythmic Complications after Parasympathetic Treatment of Bradyarrhythmias in a Coronary Care Unit, Acta Med. Scand. 190:495-498 (1971).

5. Neeld, J.B., et al: Cardiac Rate and Rhythm Changes with Atropine and Methscopolamine, Clin. Pharmacol. Ther. 17(3):290-295 (March) 1975.


Rx Only


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


Manufactured for:

Boca Pharmacal, Inc.

Coral Springs, FL 33065

www.bocapharmacal.com

1-800-354-8460


500158 Rev. 09/2011



PACKAGE LABEL.PRINCIPAL DISPLAY PANEL



[Rev. 4]



[Rev. 3]









Methscopolamine BROMIDE 
Methscopolamine bromide  tablet










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)64376-603
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Methscopolamine BROMIDE (Methscopolamine)Methscopolamine BROMIDE2.5 mg










Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
STARCH, CORN 
MAGNESIUM STEARATE 


















Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize7mm
FlavorImprint CodeBOCA;603
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
164376-603-01100 TABLET In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04062412/28/2006







Methscopolamine BROMIDE 
Methscopolamine bromide  tablet










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)64376-604
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Methscopolamine BROMIDE (Methscopolamine)Methscopolamine BROMIDE5 mg










Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
STARCH, CORN 
MAGNESIUM STEARATE 


















Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize12mm
FlavorImprint CodeBOCA;604
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
164376-604-6160 TABLET In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04062412/28/2006


Labeler - Boca Pharmacal, Inc. (170266089)

Registrant - Boca Pharmacal, Inc. (170266089)
Revised: 01/2012Boca Pharmacal, Inc.