Doan's P.M. Extra Strength

Diphenhydramine Hydrochloride:

• Pharmacological action
• Pharmacokinetics
• Why is Doan's P.M. Extra Strength Xepa-Soul Pattinson prescribed?
• Dosage and administration
• Doan's P.M. Extra Strength (Diphenhydramine Hydrochloride) Xepa-Soul Pattinson side effects, adverse reactions
• Doan's P.M. Extra Strength Xepa-Soul Pattinson contraindications
• Using during pregnancy and breastfeeding
• Special instructions
• Precautionary measures
• Doan's P.M. Extra Strength (Diphenhydramine Hydrochloride) Xepa-Soul Pattinson drug interactions
• Doan's P.M. Extra Strength Xepa-Soul Pattinson in case of emergency / overdose
• Doan's P.M. Extra Strength (Diphenhydramine Hydrochloride) reviews

Pharmacological action

Doan's P.M. Extra Strength Xepa-Soul Pattinson is a blocker of histamine H1-receptors. It has antiallergic activity, has a local anesthetic, antispasmodic and mild ganglion blocking action.

When Doan's P.M. Extra Strength (Diphenhydramine Hydrochloride) Xepa-Soul Pattinson administered orally Doan's P.M. Extra Strength (Diphenhydramine Hydrochloride) has a sedative and hypnotic effects, has a moderate antiemetic effect and has a central holinoliticheskoy activity.

When applied externally it has antiallergic effect.

Pharmacokinetics

Doan's P.M. Extra Strength (Diphenhydramine Hydrochloride) Xepa-Soul Pattinson is rapidly absorbed from the gastrointestinal tract. Bioavailability is 50%. C_max is achieved after 20-40 min (in the greatest concentration is determined in the lungs, spleen, kidneys, liver, brain and muscles). Binding to plasma proteins - 98-99%. Penetrates through the BBB. Metabolised mainly in the liver, partly - in the lungs and kidneys. T1/2 is 4-10 hours. Within one day completely removed kidneys as metabolites conjugated to glucuronic acid. Significant quantities are derived from milk and can cause sedation in infants (may be a paradoxical reaction characterized by hyperexcitability).

Why is Doan's P.M. Extra Strength Xepa-Soul Pattinson prescribed?

Allergic reactions (urticaria, hay fever, angioedema), allergic conjunctivitis, vasomotor rhinitis, Henoch-Schonlein purpura, serum sickness, itchy dermatitis, sleep disorders (monotherapy or in combination with drugs), chorea, sea and air sickness, vomiting in pregnancy, Meniere's syndrome, premedication.

Dosage and administration

Oral, IV, IM, rectal, topical, intranasal, in the conjunctival sac. Oral dose of Doan's P.M. Extra Strength Xepa-Soul Pattinson for adults is 30-50 mg 1-3 times / day. The treatment course is 10-15 days. As soporific - 50 mg at bedtime. IM in doses of 50-250 mg; IV in drip - 20-50 mg. When oral administered single dose for children under 1 year - 2-5 mg; from 2 to 5 years - 5-15 mg; of 6 to 12 years - 15-30 mg. Externally applied 1-2 times / day.

Doan's P.M. Extra Strength (Diphenhydramine Hydrochloride) Xepa-Soul Pattinson side effects, adverse reactions

Possible: a short-term numbness in the oral mucosa, drowsiness, weakness, decrease in psychomotor speed of reaction in children may be a paradoxical development of insomnia, irritability, and euphoria.

Rarely: dizziness, headache, dry mouth, nausea, photosensitivity, paresis of accommodation, poor coordination of movements, tremor.

Doan's P.M. Extra Strength Xepa-Soul Pattinson contraindications

Closure glaucoma, prostatic hypertrophy, stenosing peptic ulcer, stenosis of the bladder neck, bronchial asthma, epilepsy, hypersensitivity to Doan's P.M. Extra Strength (Diphenhydramine Hydrochloride).

Using during pregnancy and breastfeeding

During pregnancy and lactation, Doan's P.M. Extra Strength (Diphenhydramine Hydrochloride) used with caution, according to strict indications, when the expected therapeutic effect for the mother outweighs the potential risk to the fetus or infant.

Special instructions

With careful use Doan's P.M. Extra Strength (Diphenhydramine Hydrochloride) during pregnancy and lactation.

During the period of treatment with Doan's P.M. Extra Strength (Diphenhydramine Hydrochloride) Xepa-Soul Pattinson should not be exposed to solar radiation should be avoided alcohol.

Used with caution in patients involved in potentially dangerous activities requiring attention and rapid psychomotor reactions.

Precautionary measures

Doan's P.M. Extra Strength Xepa-Soul Pattinson is not recommended for SC injection. Since Doan's P.M. Extra Strength (Diphenhydramine Hydrochloride) has atropinopodobnym action should be cautious in its use: patients with recent respiratory infection in history (including asthma), increased intraocular pressure in hyperthyroidism, cardiovascular system, hypotension. Antihistamines drugs can reduce mental alertness as well as in adults and children and also cause agitation and hallucinations, convulsions and death in infants and children, especially in overdose. Precautions apply at age 60 and older because more likely to develop dizziness, sedation and hypotension. During treatment with Doan's P.M. Extra Strength (Diphenhydramine Hydrochloride) should avoid sun exposure. Should not be used during the drivers of vehicles and people, trade is connected with increased concentration. In the period of treatment should avoid drinking alcoholic beverages.

Doan's P.M. Extra Strength (Diphenhydramine Hydrochloride) Xepa-Soul Pattinson drug interactions

When Doan's P.M. Extra Strength (Diphenhydramine Hydrochloride) Xepa-Soul Pattinson applied simultaneously increases the effects of ethanol and drugs that depress the central nervous system.

With simultaneous use of Doan's P.M. Extra Strength (Diphenhydramine Hydrochloride) Xepa-Soul Pattinson and MAO inhibitors increase the anticholinergic activity of Doan's P.M. Extra Strength (Diphenhydramine Hydrochloride).

The antagonistic interaction observed with a joint appointment with psychostimulants.

Reduces the effectiveness of apomorphine as an emetic in the treatment of poisoning. Intensifies anticholinergic effects of drugs with anticholinergic activity.

Doan's P.M. Extra Strength Xepa-Soul Pattinson in case of emergency / overdose

Symptoms: dry mouth, difficulty breathing, persistent mydriasis, flushing, depression or excitement (more common in children), CNS confusion; children - the development of convulsions and death.

Treatment: induction of vomiting, gastric lavage, the prescription of activated charcoal, symptomatic and supportive therapy on a background of careful monitoring of respiration and blood pressure levels.

Magnesium Salicylate:

• Description
• Clinical pharmacology
• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Overdosage
• Dosage and administration
• How supplied
• References
• Doan's P.M. Extra Strength (Magnesium Salicylate) reviews

Doan's P.M. Extra Strength (Magnesium Salicylate) Sulfate

Injection, USP

Ansyr Plastic Syringe

Rx only

Hospira Logo

DESCRIPTION

Doan's P.M. Extra Strength (Magnesium Salicylate) Sulfate Injection, USP is a sterile solution of Doan's P.M. Extra Strength (Magnesium Salicylate) sulfate heptahydrate in Water for Injection, USP administered by the intravenous or intramuscular routes as an electrolyte replenisher or anticonvulsant. Must be diluted before intravenous use. May contain sulfuric acid and/or sodium hydroxide for pH adjustment. The pH is 5.5 to 7.0. The 50% concentration has an osmolarity of 4.06 mOsmol/mL (calc.).

The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded with the entire unit.

Doan's P.M. Extra Strength (Magnesium Salicylate) Sulfate, USP heptahydrate is chemically designated MgSO₄ - 7H₂O with molecular weight of 246.48 and occurs as colorless crystals or white powder freely soluble in water.

The plastic syringe is molded from a specially formulated polypropylene. Water permeates from inside the container at an extremely slow rate which will have an insignificant effect on solution concentration over the expected shelf life. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the syringe material.

CLINICAL PHARMACOLOGY

Doan's P.M. Extra Strength (Magnesium Salicylate) (Mg⁺⁺) is an important cofactor for enzymatic reactions and plays an important role in neurochemical transmission and muscular excitability.

As a nutritional adjunct in hyperalimentation, the precise mechanism of action for Doan's P.M. Extra Strength (Magnesium Salicylate) is uncertain. Early symptoms of hypomagnesemia (less than 1.5 mEq/liter) may develop as early as three to four days or within weeks.

Predominant deficiency effects are neurological, e.g., muscle irritability, clonic twitching and tremors. Hypocalcemia and hypokalemia often follow low serum levels of Doan's P.M. Extra Strength (Magnesium Salicylate). While there are large stores of Doan's P.M. Extra Strength (Magnesium Salicylate) present intracellularly and in the bones of adults, these stores often are not mobilized sufficiently to maintain plasma levels. Parenteral Doan's P.M. Extra Strength (Magnesium Salicylate) therapy repairs the plasma deficit and causes deficiency symptoms and signs to cease.

Doan's P.M. Extra Strength (Magnesium Salicylate) prevents or controls convulsions by blocking neuromuscular transmission and decreasing the amount of acetylcholine liberated at the end plate by the motor nerve impulse. Doan's P.M. Extra Strength (Magnesium Salicylate) is said to have a depressant effect on the central nervous system (CNS), but it does not adversely affect the woman, fetus or neonate when used as directed in eclampsia or pre-eclampsia. Normal plasma Doan's P.M. Extra Strength (Magnesium Salicylate) levels range from 1.5 to 2.5 mEq/liter.

As plasma Doan's P.M. Extra Strength (Magnesium Salicylate) rises above 4 mEq/liter, the deep tendon reflexes are first decreased and then disappear as the plasma level approaches 10 mEq/liter. At this level respiratory paralysis may occur. Heart block also may occur at this or lower plasma levels of Doan's P.M. Extra Strength (Magnesium Salicylate). Serum Doan's P.M. Extra Strength (Magnesium Salicylate) concentrations in excess of 12 mEq/L may be fatal.

Doan's P.M. Extra Strength (Magnesium Salicylate) acts peripherally to produce vasodilation. With low doses only flushing and sweating occur, but larger doses cause lowering of blood pressure. The central and peripheral effects of Doan's P.M. Extra Strength (Magnesium Salicylate) poisoning are antagonized to some extent by intravenous administration of calcium.

Pharmacokinetics

With intravenous administration the onset of anticonvulsant action is immediate and lasts about 30 minutes. Following intramuscular administration the onset of action occurs in about one hour and persists for three to four hours. Effective anticonvulsant serum levels range from 2.5 to 7.5 mEq/liter. Doan's P.M. Extra Strength (Magnesium Salicylate) is excreted solely by the kidneys at a rate proportional to the plasma concentration and glomerular filtration.

INDICATIONS AND USAGE

Doan's P.M. Extra Strength (Magnesium Salicylate) Sulfate Injection, USP is suitable for replacement therapy in Doan's P.M. Extra Strength (Magnesium Salicylate) deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those observed in hypocalcemia. In such cases, the serum Doan's P.M. Extra Strength (Magnesium Salicylate) (Mg⁺⁺) level is usually below the lower limit of normal (1.5 to 2.5 mEq/liter) and the serum calcium (Ca⁺⁺) level is normal (4.3 to 5.3 mEq/liter) or elevated.

In total parenteral nutrition (TPN), Doan's P.M. Extra Strength (Magnesium Salicylate) sulfate may be added to the nutrient admixture to correct or prevent hypomagnesemia which can arise during the course of therapy.

Doan's P.M. Extra Strength (Magnesium Salicylate) Sulfate Injection, USP is also indicated for the prevention and control of seizures (convulsions) in pre-eclampsia and eclampsia, respectively.

CONTRAINDICATIONS

Parenteral administration of the drug is contraindicated in patients with heart block or myocardial damage.

WARNINGS

FETAL HARM: Continuous administration of Doan's P.M. Extra Strength (Magnesium Salicylate) sulfate beyond 5 to 7 days to pregnant women can lead to hypocalcemia and bone abnormalities in the developing fetus. These bone abnormalities include skeletal demineralization and osteopenia. In addition, cases of neonatal fracture have been reported. The shortest duration of treatment that can lead to fetal harm is not known. Doan's P.M. Extra Strength (Magnesium Salicylate) sulfate should be used during pregnancy only if clearly needed. If Doan's P.M. Extra Strength (Magnesium Salicylate) sulfate is given for treatment of preterm labor, the woman should be informed that the efficacy and safety of such use have not been established and that use of Doan's P.M. Extra Strength (Magnesium Salicylate) sulfate beyond 5 to 7 days may cause fetal abnormalities.

ALUMINUM TOXICITY: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

Parenteral use in the presence of renal insufficiency may lead to Doan's P.M. Extra Strength (Magnesium Salicylate) intoxication. Intravenous use in the eclampsia should be reserved for immediate control of life-threatening convulsions.

PRECAUTIONS

General

Administer with caution if flushing and sweating occurs. When barbiturates, narcotics or other hypnotics (or systemic anesthetics) are to be given in conjunction with Doan's P.M. Extra Strength (Magnesium Salicylate), their dosage should be adjusted with caution because of additive CNS depressant effects of Doan's P.M. Extra Strength (Magnesium Salicylate).

Because Doan's P.M. Extra Strength (Magnesium Salicylate) is removed from the body solely by the kidneys, the drug should be used with caution in patients with renal impairment. Urine output should be maintained at a level of 100 mL or more during the four hours preceding each dose. Monitoring serum Doan's P.M. Extra Strength (Magnesium Salicylate) levels and the patient's clinical status is essential to avoid the consequences of overdosage in toxemia. Clinical indications of a safe dosage regimen include the presence of the patellar reflex (knee jerk) and absence of respiratory depression (approximately 16 breaths or more/minute). When repeated doses of the drug are given parenterally, knee jerk reflexes should be tested before each dose and if they are absent, no additional Doan's P.M. Extra Strength (Magnesium Salicylate) should be given until they return. Serum Doan's P.M. Extra Strength (Magnesium Salicylate) levels usually sufficient to control convulsions range from 3 to 6 mg/100 mL (2.5 to 5 mEq/liter). The strength of the deep tendon reflexes begins to diminish when Doan's P.M. Extra Strength (Magnesium Salicylate) levels exceed 4 mEq/liter. Reflexes may be absent at 10 mEq magnesium/liter, where respiratory paralysis is a potential hazard. An injectable calcium salt should be immediately available to counteract the potential hazards of Doan's P.M. Extra Strength (Magnesium Salicylate) intoxication in eclampsia.

50% Doan's P.M. Extra Strength (Magnesium Salicylate) Sulfate Injection, USP must be diluted to a concentration of 20% or less prior to intravenous infusion. Rate of administration should be slow and cautious, to avoid producing hypermagnesemia. The 50% solution also should be diluted to 20% or less for intramuscular injection in infants and children.

Laboratory Tests

Doan's P.M. Extra Strength (Magnesium Salicylate) sulfate injection should not be given unless hypomagnesemia has been confirmed and the serum concentration of Doan's P.M. Extra Strength (Magnesium Salicylate) is monitored. The normal serum level is 1.5 to 2.5 mEq/L.

Drug Interactions

CNS Depressants - When barbiturates, narcotics or other hypnotics (or systemic anesthetics), or other CNS depressants are to be given in conjunction with Doan's P.M. Extra Strength (Magnesium Salicylate), their dosage should be adjusted with caution because of additive CNS depressant effects of Doan's P.M. Extra Strength (Magnesium Salicylate). CNS depression and peripheral transmission defects produced by Doan's P.M. Extra Strength (Magnesium Salicylate) may be antagonized by calcium.

Neuromuscular Blocking Agents - Excessive neuromuscular block has occurred in patients receiving parenteral Doan's P.M. Extra Strength (Magnesium Salicylate) sulfate and a neuromuscular blocking agent; these drugs should be administered concomitantly with caution.

Cardiac Glycosides - Doan's P.M. Extra Strength (Magnesium Salicylate) sulfate should be administered with extreme caution in digitalized patients, because serious changes in cardiac conduction which can result in heart block may occur if administration of calcium is required to treat Doan's P.M. Extra Strength (Magnesium Salicylate) toxicity.

Pregnancy

Teratogenic Effects

Pregnancy Category D (See WARNINGS and PRECAUTIONS )

See WARNINGS and PRECAUTIONS .

Doan's P.M. Extra Strength (Magnesium Salicylate) sulfate can cause fetal abnormalities when administered beyond 5 to 7 days to pregnant women. There are retrospective epidemiological studies and case reports documenting fetal abnormalities such as hypocalcemia, skeletal demineralization, osteopenia and other skeletal abnormalities with continuous maternal administration of Doan's P.M. Extra Strength (Magnesium Salicylate) sulfate for more than 5 to 7 days.^1-10 Doan's P.M. Extra Strength (Magnesium Salicylate) sulfate injection should be used during pregnancy only if clearly needed. If this drug is used during pregnancy, the woman should be apprised of the potential harm to the fetus.

Nonteratogenic Effects

When administered by continuous intravenous infusion (especially for more than 24 hours preceding delivery) to control convulsions in a toxemic woman, the newborn may show signs of Doan's P.M. Extra Strength (Magnesium Salicylate) toxicity, including neuromuscular or respiratory depression (See OVERDOSAGE ).

Labor and Delivery

Continuous administration of Doan's P.M. Extra Strength (Magnesium Salicylate) sulfate is an unapproved treatment for preterm labor. The safety and efficacy of such use have not been established. The administration of Doan's P.M. Extra Strength (Magnesium Salicylate) sulfate outside of its approved indication in pregnant women should be by trained obstetrical personnel in a hospital setting with appropriate obstetrical care facilities.

Nursing Mothers

Since Doan's P.M. Extra Strength (Magnesium Salicylate) is distributed into milk during parenteral Doan's P.M. Extra Strength (Magnesium Salicylate) sulfate administration, the drug should be used with caution in nursing women.

Geriatrics

Geriatric patients often require reduced dosage because of impaired renal function. In patients with severe impairment, dosage should not exceed 20 grams in 48 hours. Serum Doan's P.M. Extra Strength (Magnesium Salicylate) should be monitored in such patients.

ADVERSE REACTIONS

The adverse effects of parenterally administered Doan's P.M. Extra Strength (Magnesium Salicylate) usually are the result of Doan's P.M. Extra Strength (Magnesium Salicylate) intoxication. These include flushing, sweating, hypotension, depressed reflexes, flaccid paralysis, hypothermia, circulatory collapse, cardiac and central nervous system depression proceeding to respiratory paralysis. Hypocalcemia with signs of tetany secondary to Doan's P.M. Extra Strength (Magnesium Salicylate) sulfate therapy for eclampsia has been reported.

OVERDOSAGE

Doan's P.M. Extra Strength (Magnesium Salicylate) intoxication is manifested by a sharp drop in blood pressure and respiratory paralysis. Disappearance of the patellar reflex is a useful clinical sign to detect the onset of Doan's P.M. Extra Strength (Magnesium Salicylate) intoxication. In the event of overdosage, artificial ventilation must be provided until a calcium salt can be injected intravenously to antagonize the effects of Doan's P.M. Extra Strength (Magnesium Salicylate).

For Treatment of Overdose

Artificial respiration is often required. Intravenous calcium, 10 to 20 mL of a 5% solution (diluted if desirable with isotonic sodium chloride for injection) is used to counteract effects of hypermagnesemia. Subcutaneous physostigmine, 0.5 to 1 mg may be helpful.

Hypermagnesemia in the newborn may require resuscitation and assisted ventilation via endotracheal intubation or intermittent positive pressure ventilation as well as intravenous calcium.

DOSAGE AND ADMINISTRATION

Dosage of Doan's P.M. Extra Strength (Magnesium Salicylate) sulfate must be carefully adjusted according to individual requirements and response, and administration of the drug should be discontinued as soon as the desired effect is obtained.

Both intravenous and intramuscular administration are appropriate. Intramuscular administration of the undiluted 50% solution results in therapeutic plasma levels in 60 minutes, whereas intravenous doses will provide a therapeutic level almost immediately. The rate of intravenous injection should generally not exceed 150 mg/minute (1.5 mL of a 10% concentration or its equivalent), except in severe eclampsia with seizures. Continuous maternal administration of Doan's P.M. Extra Strength (Magnesium Salicylate) sulfate in pregnancy beyond 5 to 7 days can cause fetal abnormalities.

Solutions for intravenous infusion must be diluted to a concentration of 20% or less prior to administration. The diluents commonly used are 5% Dextrose Injection, USP and 0.9% Sodium Chloride Injection, USP. Deep intramuscular injection of the undiluted (50%) solution is appropriate for adults, but the solution should be diluted to a 20% or less concentration prior to such injection in children.

In Doan's P.M. Extra Strength (Magnesium Salicylate) Deficiency

In the treatment of mild Doan's P.M. Extra Strength (Magnesium Salicylate) deficiency, the usual adult dose is 1 gram, equivalent to 8.12 mEq of Doan's P.M. Extra Strength (Magnesium Salicylate) (2 mL of the 50% solution) injected intramuscularly every six hours for four doses (equivalent to a total of 32.5 mEq of Doan's P.M. Extra Strength (Magnesium Salicylate) per 24 hours). For severe hypomagnesemia, as much as 250 mg (approximately 2 mEq) per kg of body weight (0.5 mL of the 50% solution) may be given intramuscularly within a period of four hours if necessary. Alternatively, 5 grams, (approximately 40 mEq) can be added to one liter of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP for slow intravenous infusion over a three-hour period. In the treatment of deficiency states, caution must be observed to prevent exceeding the renal excretory capacity.

In Hyperalimentation

In total parenteral nutrition, maintenance requirements for Doan's P.M. Extra Strength (Magnesium Salicylate) are not precisely known. The maintenance dose used in adults ranges from 8 to 24 mEq (1 gram to 3 grams) daily; for infants, the range is 2 to 10 mEq (0.25 gram to 1.25 grams) daily.

In Pre-eclampsia or Eclampsia

In severe pre-eclampsia or eclampsia, the total initial dose is 10 grams to 14 grams of Doan's P.M. Extra Strength (Magnesium Salicylate) sulfate. Intravenously, a dose of 4 grams to 5 grams in 250 mL of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP may be infused. Simultaneously, intramuscular doses of up to 10 grams (5 grams or 10 mL of the undiluted 50% solution in each buttock) are given. Alternatively, the initial intravenous dose of 4 grams may be given by diluting the 50% solution to a 10 or 20% concentration; the diluted fluid (40 mL of a 10% solution or 20 mL of a 20% solution) may then be injected intravenously over a period of three to four minutes. Subsequently, 4 grams to 5 grams (8 to 10 mL of the 50% solution) are injected intramuscularly into alternate buttocks every four hours as needed, depending on the continuing presence of the patellar reflex and adequate respiratory function. Alternatively, after the initial intravenous dose, some clinicians administer 1 gram to 2 grams/hour by constant intravenous infusion. Therapy should continue until paroxysms cease. A serum Doan's P.M. Extra Strength (Magnesium Salicylate) level of 6 mg/100 mL is considered optimal for control of seizures. A total daily (24 hr) dose of 30 grams to 40 grams should not be exceeded. In the presence of severe renal insufficiency, the maximum dosage of Doan's P.M. Extra Strength (Magnesium Salicylate) sulfate is 20 grams/48 hours and frequent serum Doan's P.M. Extra Strength (Magnesium Salicylate) concentrations must be obtained. Continuous use of Doan's P.M. Extra Strength (Magnesium Salicylate) sulfate in pregnancy beyond 5 to 7 days can cause fetal abnormalities.

Other Uses

In counteracting the muscle-stimulating effects of barium poisoning, the usual dose of Doan's P.M. Extra Strength (Magnesium Salicylate) sulfate is 1 gram to 2 grams given intravenously.

For controlling seizures associated with epilepsy, glomerulonephritis or hypothyroidism, the usual adult dose is 1 gram administered intramuscularly or intravenously.

In paroxysmal atrial tachycardia, Doan's P.M. Extra Strength (Magnesium Salicylate) should be used only if simpler measures have failed and there is no evidence of myocardial damage. The usual dose is 3 grams to 4 grams (30 to 40 mL of a 10% solution) administered intravenously over 30 seconds with extreme caution.

For reduction of cerebral edema, 2.5 grams (25 mL of a 10% solution) is given intravenously.

Incompatibilities

Doan's P.M. Extra Strength (Magnesium Salicylate) sulfate in solution may result in a precipitate formation when mixed with solutions containing:

Alcohol (in high Heavy Metals

concentrations) Hydrocortisone sodium

Alkali carbonates and succinate

bicarbonates Phosphates

Alkali hydroxides Polymixin B sulfate

Arsenates Procaine hydrochloride

Barium Salicylates

Calcium Strontium

Clindamycin phosphate Tartrates

The potential incompatibility will often be influenced by the changes in the concentration of reactants and the pH of the solutions.

It has been reported that Doan's P.M. Extra Strength (Magnesium Salicylate) may reduce the antibiotic activity of streptomycin, tetracycline and tobramycin when given together.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HOW SUPPLIED

Doan's P.M. Extra Strength (Magnesium Salicylate) Sulfate Injection, USP is supplied in single-dose containers as follows:

Do not administer unless solution is clear and container is undamaged. Discard unused portion.

Store at 20 to 25°C (68 to 77°F).

REFERENCES

• Yokoyama K, Takahashi N, Yada Y. Prolonged maternal Doan's P.M. Extra Strength (Magnesium Salicylate) administration and bone metabolism in neonates. Early Hum Dev. 2010;86(3):187-91. Epub 2010 Mar 12.
• Wedig KE, Kogan J, Schorry EK et al. Skeletal demineralization and fractures caused by fetal Doan's P.M. Extra Strength (Magnesium Salicylate) toxicity. J. Perinatol. 2006; 26(6):371-4.
• Nassar AH, Sakhel K, Maarouf H, et al. Adverse maternal and neonatal outcome of prolonged course of Doan's P.M. Extra Strength (Magnesium Salicylate) sulfate tocolysis. Acta Obstet Gynecol Scan. 2006;85(9):1099-103.
• Malaeb SN, Rassi A, Haddad MC. Bone mineralization in newborns whose mothers received Doan's P.M. Extra Strength (Magnesium Salicylate) sulphate for tocolysis of premature labor. Pediatr Radiol. 2004;34(5):384-6. Epub 2004 Feb 18.
• Matsuda Y, Maeda Y, Ito M, et al. Effect of Doan's P.M. Extra Strength (Magnesium Salicylate) sulfate treatment on neonatal bone abnormalities. Gynecol Obstet Invest. 1997;44(2):82-8.
• Schanler RJ, Smith LG, Burns PA. Effects of long-term maternal intravenous Doan's P.M. Extra Strength (Magnesium Salicylate) sulfate therapy on neonatal calcium metabolism and bone mineral content. Gynecol Obstet Invest. 1997;43(4):236-41.
• Santi MD, Henry GW, Douglas GL. Doan's P.M. Extra Strength (Magnesium Salicylate) sulfate treatment of preterm labor as a cause of abnormal neonatal bone mineralization. J Pediatr Orthrop. 1994;14(2):249-53.
• Holcomb WL, Shackelford GD, Petrie RH. Doan's P.M. Extra Strength (Magnesium Salicylate) tocolysis and neonatal bone abnormalities; a controlled study. Obstet Gynecol. 1991; 78(4):611-4.
• Cumming WA, Thomas VJ. Hypermagnesemia: a cause of abnormal metaphyses in the neonate. Am J Roentgenol. 1989; 152(5):1071-2.
• Lamm CL, Norton KL, Murphy RJ. Congenital rickets associated with Doan's P.M. Extra Strength (Magnesium Salicylate) sulfate infusion for tocolysis. J Pediatr. 1988; 113(6):1078-82.
• McGuinness GA, Weinstein MM, Cruikshank DP, et al. Effects of Doan's P.M. Extra Strength (Magnesium Salicylate) sulfate treatment on perinatal calcium metabolism. II. Neonatal responses. Obstet Gynecol. 1980; 56(5): 595-600.
• Riaz M, Porat R, Brodsky NL, et al. The effects of maternal Doan's P.M. Extra Strength (Magnesium Salicylate) sulfate treatment on newborns: a prospective controlled study. J. Perinatol. 1998;18(6 pt 1):449-54.

Hospira, Inc., Lake Forest, IL 60045 USA

LAB-1024-1.0

April 2017

Hospira Logo

50% Doan's P.M. Extra Strength (Magnesium Salicylate) Sulfate 5 g/10 mL (500 mg/mL)

Rx only

NDC 0409-1754-10

10 mL Single-dose syringe

50% Doan's P.M. Extra Strength (Magnesium Salicylate) Sulfate Injection, USP

5 g/10 mL (500 mg/mL) (4 mEq Mg++/mL)

MUST BE DILUTED FOR INTRAVENOUS USE.

For Intravenous or Intramuscular Use. Sterile. 4.06 mOsmol/mL (calc.).

Contains no more than 75 mcg/L of aluminum.

Hospira, Inc., Lake Forest, IL 60045 USA

Hospira

RL-6891