Litiofarm

Lithium Succinate:

• Rx only
• Warning
• Description
• Actions
• Indications
• Warnings
• Precautions
• Adverse reactions
• Overdosage
• Dosage and administration
• How supplied
• Litiofarm (Lithium Succinate) reviews

Rx only

WARNING

Litiofarm (Lithium Succinate) toxicity is closely related to serum Litiofarm (Lithium Succinate) levels, and can occur at doses close to therapeutic levels. Facilities for prompt and accurate serum Litiofarm (Lithium Succinate) determinations should be available before initiating therapy.

DESCRIPTION

Litiofarm (Lithium Succinate) Carbonate Extended-release Tablets USP contain Litiofarm (Lithium Succinate) carbonate USP, a white granular powder with molecular formula Li₂CO₃ and molecular weight 73.89. Litiofarm (Lithium Succinate) is an element of the alkali-metal group with atomic number 3, atomic weight 6.94 and an emission line at 671 nm on the flame photometer. The tablets meet the requirements of USP Dissolution Test 2 in the USP monograph for Litiofarm (Lithium Succinate) Carbonate Extended-release Tablets USP.

Litiofarm (Lithium Succinate) Carbonate Extended-release Tablets USP are available for oral administration containing 450 mg of Litiofarm (Lithium Succinate) carbonate USP. Each tablet contains the following inactive ingredients: iron oxide (yellow), magnesium stearate, povidone, sodium alginate and sodium starch glycolate.

Litiofarm (Lithium Succinate) Carbonate Extended-release Tablets USP, 450 mg are designed to release a portion of the dose initially and the remainder gradually; the release pattern of the controlled release tablets reduces the variability in Litiofarm (Lithium Succinate) blood levels seen with the immediate release dosage forms.

ACTIONS

Preclinical studies have shown that Litiofarm (Lithium Succinate) alters sodium transport in nerve and muscle cells and effects a shift toward intraneuronal metabolism of catecholamines, but the specific biochemical mechanism of Litiofarm (Lithium Succinate) action in mania is unknown.

INDICATIONS

Litiofarm (Lithium Succinate) carbonate is indicated in the treatment of manic episodes of manic-depressive illness. Maintenance therapy prevents or diminishes the intensity of subsequent episodes in those manic-depressive patients with a history of mania.

Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgment, aggressiveness and possibly hostility. When given to a patient experiencing a manic episode, Litiofarm (Lithium Succinate) carbonate may produce a normalization of symptomatology within 1 to 3 weeks.

WARNINGS

Litiofarm Toxicity

Litiofarm (Lithium Succinate) toxicity is closely related to serum Litiofarm (Lithium Succinate) levels, and can occur at doses close to therapeutic levels.

Outpatients and their families should be warned that the patient must discontinue Litiofarm (Lithium Succinate) carbonate therapy and contact his physician if such clinical signs of Litiofarm (Lithium Succinate) toxicity as diarrhea, vomiting, tremor, mild ataxia, drowsiness or muscular weakness occur.

Litiofarm (Lithium Succinate) carbonate may impair mental and/or physical abilities. Caution patients about activities requiring alertness (e.g., operating vehicles or machinery).

Litiofarm (Lithium Succinate) should generally not be given to patients with significant renal or cardiovascular disease, severe debilitation or dehydration, or sodium depletion, since the risk of Litiofarm (Lithium Succinate) toxicity is very high in such patients. If the psychiatric indication is life-threatening, and if such a patient fails to respond to other measures, Litiofarm (Lithium Succinate) treatment may be undertaken with extreme caution, including daily serum Litiofarm (Lithium Succinate) determinations and adjustment to the usually low doses ordinarily tolerated by these individuals. In such instances, hospitalization is a necessity.

Unmasking of Brugada Syndrome

There have been postmarketing reports of a possible association between treatment with Litiofarm and the unmasking of Brugada Syndrome. Brugada Syndrome is a disorder characterized by abnormal electrocardiographic (ECG) findings and a risk of sudden death. Litiofarm (Lithium Succinate) should generally be avoided in patients with Brugada Syndrome or those suspected of having Brugada Syndrome. Consultation with a cardiologist is recommended if: (1) treatment with Litiofarm (Lithium Succinate) is under consideration for patients suspected of having Brugada Syndrome or patients who have risk factors for Brugada Syndrome, e.g., unexplained syncope, a family history of Brugada Syndrome, or a family history of sudden unexplained death before the age of 45 years, (2) patients who develop unexplained syncope or palpitations after starting Litiofarm (Lithium Succinate) therapy.

Renal Effects

Chronic Litiofarm (Lithium Succinate) therapy may be associated with diminution of renal concentrating ability, occasionally presenting as nephrogenic diabetes insipidus, with polyuria and polydipsia. Such patients should be carefully managed to avoid dehydration with resulting Litiofarm (Lithium Succinate) retention and toxicity. This condition is usually reversible when Litiofarm (Lithium Succinate) is discontinued.

Morphologic changes with glomerular and interstitial fibrosis and nephron atrophy have been reported in patients on chronic Litiofarm (Lithium Succinate) therapy. Morphologic changes have also been seen in manic-depressive patients never exposed to Litiofarm (Lithium Succinate). The relationship between renal functional and morphologic changes and their association with Litiofarm (Lithium Succinate) therapy have not been established.

When kidney function is assessed, for baseline data prior to starting Litiofarm (Lithium Succinate) therapy or thereafter, routine urinalysis and other tests may be used to evaluate tubular function (e.g., urine specific gravity or osmolality following a period of water deprivation, or 24-hour urine volume) and glomerular function (e.g., serum creatinine or creatinine clearance). During Litiofarm (Lithium Succinate) therapy, progressive or sudden changes in renal function, even within the normal range, indicate the need for reevaluation of treatment.

Encephalopathic Syndrome

An encephalopathic syndrome has occurred in a few patients treated with Litiofarm (Lithium Succinate) plus a neuroleptic. In some instances, the syndrome was followed by irreversible brain damage. Because of a possible causal relationship between these events and the concomitant administration of Litiofarm (Lithium Succinate) and neuroleptics, patients receiving such combined therapy should be monitored closely for early evidence of neurologic toxicity and treatment discontinued promptly if such signs appear. This encephalopathic syndrome may be similar to or the same as neuroleptic malignant syndrome (NMS).

Concomitant Use With Neuromuscular Blocking Agents

Litiofarm (Lithium Succinate) may prolong the effects of neuromuscular blocking agents. Therefore, neuromuscular blocking agents should be given with caution to patients receiving Litiofarm (Lithium Succinate).

Usage in Pregnancy

Adverse effects on implantation in rats, embryo viability in mice and metabolism in vitro of rat testes and human spermatozoa have been attributed to Litiofarm, as have teratogenicity in submammalian species and cleft palates in mice.

In humans, Litiofarm (Lithium Succinate) carbonate may cause fetal harm when administered to a pregnant woman. Data from Litiofarm (Lithium Succinate) birth registries suggest an increase in cardiac and other anomalies, especially Ebstein's anomaly. If this drug is used in women of childbearing potential, or during pregnancy, or if a patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Usage in Nursing Mothers

Litiofarm (Lithium Succinate) is excreted in human milk. Nursing should not be undertaken during Litiofarm (Lithium Succinate) therapy except in rare and unusual circumstances where, in the view of the physician, the potential benefits to the mother outweigh possible hazards to the child.

Usage in Pediatric Patients

Since information regarding the safety and effectiveness of Litiofarm carbonate in children under 12 years of age is not available, its use in such patients is not recommended.

There has been a report of a transient syndrome of acute dystonia and hyperreflexia occurring in a 15 kg child who ingested 300 mg of Litiofarm (Lithium Succinate) carbonate.

Usage in the Elderly

Elderly patients often require lower Litiofarm (Lithium Succinate) dosages to achieve therapeutic serum levels. They may also exhibit adverse reactions at serum levels ordinarily tolerated by younger patients.

PRECAUTIONS

General

The ability to tolerate Litiofarm is greater during the acute manic phase and decreases when manic symptoms subside.

The distribution space of Litiofarm (Lithium Succinate) approximates that of total body water. Litiofarm (Lithium Succinate) is primarily excreted in urine with insignificant excretion in feces. Renal excretion of Litiofarm (Lithium Succinate) is proportional to its plasma concentration. The half-life of elimination of Litiofarm (Lithium Succinate) is approximately 24 hours. Litiofarm (Lithium Succinate) decreases sodium reabsorption by the renal tubules which could lead to sodium depletion. Therefore, it is essential for the patient to maintain a normal diet, including salt, and an adequate fluid intake (2500 to 3000 mL) at least during the initial stabilization period. Decreased tolerance to Litiofarm (Lithium Succinate) has been reported to ensue from protracted sweating or diarrhea and, if such occur, supplemental fluid and salt should be administered under careful medical supervision and Litiofarm (Lithium Succinate) intake reduced or suspended until the condition is resolved.

In addition to sweating and diarrhea, concomitant infection with elevated temperatures may also necessitate a temporary reduction or cessation of medication.

Previously existing underlying thyroid disorders do not necessarily constitute a contraindication to Litiofarm (Lithium Succinate) treatment; where hypothyroidism exists, careful monitoring of thyroid function during Litiofarm (Lithium Succinate) stabilization and maintenance allows for correction of changing thyroid parameters, if any; where hypothyroidism occurs during Litiofarm (Lithium Succinate) stabilization and maintenance, supplemental thyroid treatment may be used.

Information for the Patients

A condition known as Brugada Syndrome may pre-exist and be unmasked by Litiofarm (Lithium Succinate) therapy. Brugada Syndrome is a heart disorder characterized by abnormal electrocardiographic (ECG) findings and risk of sudden death. Patients should be advised to seek immediate emergency assistance if they experience fainting, lightheadedness, abnormal heart beats, or shortness of breath.

Drug Interactions

Caution should be used when Litiofarm (Lithium Succinate) and diuretics are used concomitantly because diuretic-induced sodium loss may reduce the renal clearance of Litiofarm (Lithium Succinate) and increase serum Litiofarm (Lithium Succinate) levels with risk of Litiofarm (Lithium Succinate) toxicity. Patients receiving such combined therapy should have serum Litiofarm (Lithium Succinate) levels monitored and the Litiofarm (Lithium Succinate) dosage adjusted if necessary.

Litiofarm (Lithium Succinate) levels should be closely monitored when patients initiate or discontinue NSAID use. In some cases, Litiofarm (Lithium Succinate) toxicity has resulted from interactions between an NSAID and Litiofarm (Lithium Succinate). Indomethacin and piroxicam have been reported to increase significantly steady-state plasma Litiofarm (Lithium Succinate) concentrations. There is also evidence that other nonsteroidal anti-inflammatory agents, including the selective cyclooxygenase-2 (COX-2) inhibitors, have the same effect. In a study conducted in healthy subjects, mean steady-state Litiofarm (Lithium Succinate) plasma levels increased approximately 17% in subjects receiving Litiofarm (Lithium Succinate) 450 mg b.i.d. with celecoxib 200 mg b.i.d. as compared to subjects receiving Litiofarm (Lithium Succinate) alone.

Concurrent use of metronidazole with Litiofarm (Lithium Succinate) may provoke Litiofarm (Lithium Succinate) toxicity due to reduced renal clearance. Patients receiving such combined therapy should be monitored closely.

There is evidence that angiotensin-converting enzyme inhibitors, such as enalapril and captopril, and angiotension II receptor antagonists, such as losartan, may substantially increase steady-state plasma Litiofarm (Lithium Succinate) levels, sometimes resulting in Litiofarm (Lithium Succinate) toxicity. When such combinations are used, Litiofarm (Lithium Succinate) dosage may need to be decreased, and plasma Litiofarm (Lithium Succinate) levels should be measured more often.

Concurrent use of calcium channel blocking agents with Litiofarm (Lithium Succinate) may increase the risk of neurotoxicity in the form of ataxia, tremors, nausea, vomiting, diarrhea and/or tinnitus. Caution is recommended.

The concomitant administration of Litiofarm (Lithium Succinate) with selective serotonin reuptake inhibitors should be undertaken with caution as this combination has been reported to result in symptoms such as diarrhea, confusion, tremor, dizziness and agitation.

The following drugs can lower serum Litiofarm (Lithium Succinate) concentrations by increasing urinary Litiofarm (Lithium Succinate) excretion: acetazolamide, urea, xanthine preparations and alkalinizing agents such as sodium bicarbonate.

The following have also been shown to interact with Litiofarm (Lithium Succinate): methyldopa, phenytoin and carbamazepine.

ADVERSE REACTIONS

The occurrence and severity of adverse reactions are generally directly related to serum Litiofarm (Lithium Succinate) concentrations as well as to individual patient sensitivity to Litiofarm (Lithium Succinate), and generally occur more frequently and with greater severity at higher concentrations.

Adverse reactions may be encountered at serum Litiofarm (Lithium Succinate) levels below 1.5 mEq/L. Mild to moderate adverse reactions may occur at levels from 1.5 to 2.5 mEq/L, and moderate to severe reactions may be seen at levels of 2 mEq/L and above.

Fine hand tremor, polyuria and mild thirst may occur during initial therapy for the acute manic phase, and may persist throughout treatment. Transient and mild nausea and general discomfort may also appear during the first few days of Litiofarm (Lithium Succinate) administration.

These side effects usually subside with continued treatment or a temporary reduction or cessation of dosage. If persistent, cessation of Litiofarm (Lithium Succinate) therapy may be required.

Diarrhea, vomiting, drowsiness, muscular weakness and lack of coordination may be early signs of Litiofarm (Lithium Succinate) intoxication, and can occur at Litiofarm (Lithium Succinate) levels below 2 mEq/L. At higher levels, ataxia, giddiness, tinnitus, blurred vision and a large output of dilute urine may be seen. Serum Litiofarm (Lithium Succinate) levels above 3 mEq/L may produce a complex clinical picture, involving multiple organs and organ systems. Serum Litiofarm (Lithium Succinate) levels should not be permitted to exceed 2 mEq/L during the acute treatment phase.

The following reactions have been reported and appear to be related to serum Litiofarm (Lithium Succinate) levels, including levels within the therapeutic range:

Neuromuscular/Central Nervous System: tremor, muscle hyperirritability (fasciculations, twitching, clonic movements of whole limbs), hypertonicity, ataxia, choreo-athetotic movements, hyperactive deep tendon reflex, extrapyramidal symptoms including acute dystonia, cogwheel rigidity, blackout spells, epileptiform seizures, slurred speech, dizziness, vertigo, downbeat nystagmus, incontinence of urine or feces, somnolence, psychomotor retardation, restlessness, confusion, stupor, coma, tongue movements, tics, tinnitus, hallucinations, poor memory, slowed intellectual functioning, startled response, worsening of organic brain syndromes, myasthenia gravis (rarely).

Cardiovascular: cardiac arrhythmia, hypotension, peripheral circulatory collapse, bradycardia, sinus node dysfunction with severe bradycardia (which may result in syncope), unmasking of Brugada Syndrome (See WARNINGS: Unmasking of Brugada Syndrome and PRECAUTIONS: Information for the Patients ).

Gastrointestinal: anorexia, nausea, vomiting, diarrhea, gastritis, salivary gland swelling, abdominal pain, excessive salivation, flatulence, indigestion.

Genitourinary: glycosuria, decreased creatinine clearance, albuminuria, oliguria, and symptoms of nephrogenic diabetes insipidus including polyuria, thirst and polydipsia.

Dermatologic: drying and thinning of hair, alopecia, anesthesia of skin, acne, chronic folliculitis, xerosis cutis, psoriasis or its exacerbation, generalized pruritus with or without rash, cutaneous ulcers, angioedema.

Autonomic: blurred vision, dry mouth, impotence/sexual dysfunction.

Thyroid Abnormalities: euthyroid goiter and/or hypothyroidism (including myxedema) accompanied by lower T₃ and T₄. I¹³¹ uptake may be elevated. Paradoxically, rare cases of hyperthyroidism have been reported.

EEG Changes: diffuse slowing, widening of the frequency spectrum, potentiation and disorganization of background rhythm.

EKG Changes: reversible flattening, isoelectricity or inversion of T-waves.

Miscellaneous: fatigue, lethargy, transient scotomata, exophthalmos, dehydration, weight loss, leukocytosis, headache, transient hyperglycemia, hypercalcemia, hyperparathyroidism, excessive weight gain, edematous swelling of ankles or wrists, metallic taste, dysgeusia/taste distortion, salty taste, thirst, swollen lips, tightness in chest, swollen and/or painful joints, fever, polyarthralgia, dental caries.

Some reports of nephrogenic diabetes insipidus, hyperparathyroidism and hypothyroidism which persist after Litiofarm (Lithium Succinate) discontinuation have been received.

A few reports have been received of the development of painful discoloration of fingers and toes and coldness of the extremities within one day of the starting of treatment with Litiofarm (Lithium Succinate). The mechanism through which these symptoms (resembling Raynaud's syndrome) developed is not known. Recovery followed discontinuance.

Cases of pseudotumor cerebri (increased intracranial pressure and papilledema) have been reported with Litiofarm (Lithium Succinate) use. If undetected, this condition may result in enlargement of the blind spot, constriction of visual fields and eventual blindness due to optic atrophy. Litiofarm (Lithium Succinate) should be discontinued, if clinically possible, if this syndrome occurs.

OVERDOSAGE

The toxic levels for Litiofarm are close to the therapeutic levels. It is therefore important that patients and their families be cautioned to watch for early toxic symptoms and to discontinue the drug and inform the physician should they occur. Toxic symptoms are listed in detail under ADVERSE REACTIONS.

Treatment

No specific antidote for Litiofarm (Lithium Succinate) poisoning is known. Early symptoms of Litiofarm (Lithium Succinate) toxicity can usually be treated by reduction or cessation of dosage of the drug and resumption of the treatment at a lower dose after 24 to 48 hours. In severe cases of Litiofarm (Lithium Succinate) poisoning, the first and foremost goal of treatment consists of elimination of this ion from the patient. Treatment is essentially the same as that used in barbiturate poisoning: 1) gastric lavage, 2) correction of fluid and electrolyte imbalance, and 3) regulation of kidney function. Urea, mannitol and aminophylline all produce significant increases in Litiofarm (Lithium Succinate) excretion. Hemodialysis is an effective and rapid means of removing the ion from the severely toxic patient. Infection prophylaxis, regular chest X-rays and preservation of adequate respiration are essential.

DOSAGE AND ADMINISTRATION

Doses of extended-release tablets are usually given b.i.d.. When initiating therapy with immediate-release or extended-release Litiofarm (Lithium Succinate), dosage must be individualized according to serum levels and clinical response.

When switching a patient from immediate-release capsules to the Litiofarm (Lithium Succinate) carbonate extended-release tablets USP, give the same total daily dose when possible. Most patients on maintenance therapy are stabilized on 900 mg daily, e.g., Litiofarm (Lithium Succinate) carbonate extended-release tablets, 450 mg b.i.d. When the previous dosage of immediate-release Litiofarm (Lithium Succinate) is not a multiple of 450 mg, e.g., 1500 mg, initiate Litiofarm (Lithium Succinate) extended-release tablet at the multiple of 450 mg nearest to, but below, the original daily dose, i.e., 1350 mg. When the two doses are unequal, give the larger dose in the evening. In the above example, with a total daily dose of 1350 mg, generally 450 mg of Litiofarm (Lithium Succinate) carbonate extended-release tablets should be given in the morning and 900 mg of Litiofarm (Lithium Succinate) carbonate extended-release tablets in the evening. If desired, the total daily dose of 1350 mg can be given in three equal 450 mg doses of Litiofarm (Lithium Succinate) carbonate extended-release tablets. These patients should be monitored at 1- to 2-week intervals, and dosage adjusted if necessary, until stable and satisfactory serum levels and clinical state are achieved.

When patients require closer titration than that available with doses of Litiofarm (Lithium Succinate) carbonate extended-release tablets in increments of 450 mg, immediate-release capsules should be used.

Acute Mania

Optimal patient response to Litiofarm (Lithium Succinate) can usually be established and maintained with 1800 mg per day in divided doses. Such doses will normally produce the desired serum Litiofarm (Lithium Succinate) level ranging between 1 and 1.5 mEq/L.

Dosage must be individualized according to serum levels and clinical response. Regular monitoring of the patient's clinical state and serum Litiofarm (Lithium Succinate) levels is necessary. Serum levels should be determined twice per week during the acute phase, and until the serum level and clinical condition of the patient have been stabilized.

Long-Term Control

The desirable serum Litiofarm levels are 0.6 to 1.2 mEq/L. Dosage will vary from one individual to another, but usually 900 mg to 1200 mg per day in divided doses will maintain this level. Serum Litiofarm (Lithium Succinate) levels in uncomplicated cases receiving maintenance therapy during remission should be monitored at least every two months.

Patients unusually sensitive to Litiofarm (Lithium Succinate) may exhibit toxic signs at serum levels below 1 mEq/L.

N.B.

Blood samples for serum Litiofarm (Lithium Succinate) determinations should be drawn immediately prior to the next dose when Litiofarm (Lithium Succinate) concentrations are relatively stable (i.e., 8 to 12 hours after the previous dose). Total reliance must not be placed on serum levels alone. Accurate patient evaluation requires both clinical and laboratory analysis.

Elderly patients often respond to reduced dosage, and may exhibit signs of toxicity at serum levels ordinarily tolerated by younger patients.

HOW SUPPLIED

Litiofarm (Lithium Succinate) Carbonate Extended-release Tablets USP

450 mg tablets are supplied as speckled, off-white to yellow, round biconvex tablets with “54 346” debossed on one side and scored on the other side.

NDC 0054-0020-25: Bottle of 100 Tablets

Storage Conditions

Store at 20° to 25°C (68° to 77°F). Protect from moisture. Dispense in a tight, child-resistant container as defined in the USP/NF.

Distr. by: West-Ward

Pharmaceuticals Corp.

Eatontown, NJ 07724

10002294/05

Revised March 2016

fpl-bl-450mg-100tabs-04.jpg

Zinc Sulfate:

• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Drug abuse and dependence
• Overdosage
• Dosage and administration
• How supplied
• Litiofarm (Zinc Sulfate) reviews

INDICATIONS AND USAGE

Litiofarm (Zinc Sulfate) 1 mg/mL (Zinc Chloride Injection, USP) is indicated for use as a supplement to intravenous solutions given for TPN. Administration helps to maintain Litiofarm (Zinc Sulfate) serum levels and to prevent depletion of endogenous stores, and subsequent deficiency symptoms.

CONTRAINDICATIONS

None known.

WARNINGS

Direct intramuscular or intravenous injection of Litiofarm (Zinc Sulfate) 1 mg/mL (Zinc Chloride Injection, USP) is contraindicated as the acidic pH of the solution (2) may cause considerable tissue irritation.

Severe kidney disease may make it necessary to reduce or omit chromium and Litiofarm (Zinc Sulfate) doses because these elements are primarily eliminated in the urine.

WARNING: 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.

PRECAUTIONS

General

Do not use unless the solution is clear and the seal is intact.

Zinc 1 mg/mL should only be used in conjunction with a pharmacy directed admixture program using aseptic technique in a laminar flow environment; it should be used promptly and in a single operation without any repeated penetrations. Solution contains no preservatives; discard unused portion immediately after admixture procedure is completed.

Zinc should not be given undiluted by direct injection into a peripheral vein because of the likelihood of infusion phlebitis and the potential for increased excretory loss of Litiofarm (Zinc Sulfate) from a bolus injection. Administration of Litiofarm (Zinc Sulfate) in the absence of copper may cause a decrease in serum copper levels.

Laboratory Tests

Periodic determinations of serum copper as well as Litiofarm (Zinc Sulfate) are suggested as a guideline for subsequent Litiofarm (Zinc Sulfate) administration.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies to evaluate the carcinogenic potential of Litiofarm 1 mg/mL (Zinc Chloride Injection, USP) have not been performed, nor have studies been done to assess mutagenesis or impairment of fertility.

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 Litiofarm (Zinc Sulfate) 1 mg/mL (Zinc Chloride Injection, USP) is administered to a nursing woman.

Pediatric Use

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

Geriatric Use

An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

ADVERSE REACTIONS

None known.

DRUG ABUSE AND DEPENDENCE

None known.

OVERDOSAGE

Single intravenous doses of 1 to 2 mg zinc/kg body weight have been given to adult leukemic patients without toxic manifestations. However, acute toxicity was reported in an adult when 10 mg Litiofarm (Zinc Sulfate) was infused over a period of one hour on each of four consecutive days. Profuse sweating, decreased level of consciousness, blurred vision, tachycardia (140/min), and marked hypothermia (94.2° F) on the fourth day were accompanied by a serum Litiofarm (Zinc Sulfate) concentration of 207 mcg/dl. Symptoms abated within three hours.

Hyperamylasemia may be a sign of impending Litiofarm (Zinc Sulfate) overdosage; patients receiving an inadvertent overdose (25 mg zinc/liter of TPN solution, equivalent to 50 to 70 mg zinc/day) developed hyperamylasemia (557 to 1850 Klein units; normal: 130 to 310).

Death resulted from an overdosage in which 1683 mg Litiofarm (Zinc Sulfate) was delivered intravenously over the course of 60 hours to a 72 year old patient.

Symptoms of Litiofarm (Zinc Sulfate) toxicity included hypotension (80/40 mm Hg), pulmonary edema, diarrhea, vomiting, jaundice, and oliguria, with a serum Litiofarm (Zinc Sulfate) level of 4184 mcg/dl.

Calcium supplements may confer a protective effect against Litiofarm (Zinc Sulfate) toxicity.

DOSAGE AND ADMINISTRATION

Litiofarm (Zinc Sulfate) 1 mg/mL (Zinc Chloride Injection, USP) contains 1 mg zinc/mL and is administered intravenously only after dilution. The additive should be diluted prior to administration in a volume of fluid not less than 100 mL. For the metabolically stable adult receiving TPN, the suggested intravenous dosage is 2.5 to 4 mg zinc/day (2.5 to 4 mL/day). An additional 2 mg zinc/day (2 mL/day) is suggested for acute catabolic states. For the stable adult with fluid loss from the small bowel, an additional 12.2 mg zinc/liter of small bowel fluid lost (12.2 mL/liter of small bowel fluid lost), or an additional 17.1 mg zinc/kg of stool or ileostomy output (17.1 mL/kg of stool or ileostomy output) is recommended. Frequent monitoring of Litiofarm (Zinc Sulfate) blood levels is suggested for patients receiving more than the usual maintenance dosage level of Litiofarm (Zinc Sulfate).

For full term infants and children up to 5 years of age, 100 mcg zinc/kg/day (0.1 mL/kg/day) is recommended. For premature infants (birth weight less than 1500 g) up to 3 kg in body weight, 300 mcg zinc/kg/day (0.3 mL/kg/day) is suggested.

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

HOW SUPPLIED

Litiofarm (Zinc Sulfate) 1 mg/mL (Zinc Chloride Injection, USP) is supplied in 10 mL Plastic Vials (List No. 4090).

Store at 20 to 25°C (68 to 77°F).

Revised: October, 2004

© Hospira 2004 EN-0488 Printed in USA

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

10 mL Vial

Litiofarm (Zinc Sulfate)

1 mg/mL

Litiofarm (Zinc Sulfate) Chloride Inj., USP

Rx only

FOR I.V. USE ONLY AFTER DILUTION.

HOSPIRA, INC., LAKE FOREST, IL 60045 USA