Ana (Epinephrine – Chlorpheniramine)

ANA-KIT®

Bayer

Epinephrine – Chlorpheniramine Maleate

Allergy Therapy

Action And Clinical Pharmacology: Epinephrine: The most valuable drug for the emergency treatment of severe allergic reactions is epinephrine. The vasoconstrictor effect of epinephrine on the capillary directly antagonizes the generalized vasodilation produced by histamine. Epinephrine reverses the increased permeability of dilated capillaries to plasma. The shock of severe allergic reactions is due to the loss of circulating blood volume by pooling in the dilated capillary beds and loss of plasma into the tissues. Epinephrine quickly restores circulating blood volume and blood pressure by constricting the capillary bed. The itching during episodes of hives or angioedema is promptly relieved by epinephrine. Epinephrine is a powerful relaxer of the smooth muscle of the bronchioles, stomach, intestine, pregnant uterus and urinary bladder wall. The bronchospasm, wheezing and dyspnea of the acute allergic reactions are relieved. Where abdominal cramping, defecation or involuntary urination have occurred during severe allergic attacks, epinephrine rapidly produces relief. S.C. or i.m. administered epinephrine has a rapid onset and short duration of action. S.C. administration during asthmatic attacks may produce bronchodilation within 5 to 10 minutes, and maximal effects may occur within 20 minutes.

Chlorpheniramine: Chlorpheniramine is an effective agent in nullifying the characteristic effects of histamine and is especially valuable in the prophylaxis and relief of many allergic symptoms. It is readily absorbed from the intestinal tract and released into the tissues from the bloodstream. This action is both prompt and sustained. Elimination of the drug is such that there is a low incidence of side effects.

Indications And Clinical Uses: For use by adults and pediatric patients under the following situations: 1. Allergic reactions including anaphylactic shock due to stinging insects (primarily of the Hymenoptera order, which includes bees, wasps, hornets, yellow jackets, bumble bees, and fire ants). 2. Severe allergic or anaphylactoid reactions due to allergy injections, exposures to pollens, dusts, molds, foods, drugs, and exercise or unknown substances (so-called idiopathic anaphylaxis).

In the sensitive patient, severe allergic reactions and anaphylactic shock may occur within minutes of the insect sting or exposure to an allergenic substance.

Symptoms may include bronchoconstriction, wheezing, sneezing, hoarseness, urticaria, angioedema, erythema, pruritus, tachycardia, thready pulse, falling blood pressure, sense of oppression or impending doom, disorientation, cramping abdominal pain, incontinence, faintness, and loss of consciousness.

The Ana-Kit is compactly designed to be carried and used by patients when severe symptoms arise, and the patient is out of reach of immediate attention by a doctor or hospital.

Contra-Indications: Epinephrine must not be given intra-arterially as marked vasoconstriction may result in gangrene.

This unit is not intended for i.v. use. Further dilution would be necessary and is not practical with this emergency syringe.

Epinephrine Injection USP (1:1 000) must not be used if there is hypersensitivity to any of the components.

Epinephrine is contraindicated in narrow-angle glaucoma; cardiogenic, traumatic, or hemorrhagic shock; cardiac dilation; cerebral arteriosclerosis; and organic brain damage.

Epinephrine should not be used to counteract circulatory collapse or hypotension due to phenothiazines, since such agents may reverse the pressor effect of epinephrine, leading to a further lowering of blood pressure.

Epinephrine should not be administered concomitantly with other sympathomimetic agents, since the effects are additive and may be detrimental to the patient.

Chlorpheniramine: No known contraindications.

Manufacturers’ Warnings In Clinical States: Epinephrine: Overdosage or accidental i.v. administration of conventional s.c. doses may induce severe or fatal hypertension, or cerebrovascular hemorrhage. Fatalities may also occur from pulmonary edema resulting from peripheral constriction and cardiac stimulation. The marked pressor effects may be counteracted by use of rapidly acting vasodilators, such as the nitrites and alpha-adrenergic blockers.

Deaths have been reported in asthmatics treated with epinephrine following the use of isoproterenol or orciprenaline.

Epinephrine is the preferred treatment for serious allergic or other emergency situations even though this product contains sodium bisulfite, a sulfite that may in other products cause allergic-type reactions including anaphylactic symptoms or life-threatening or less severe asthmatic episodes in certain susceptible persons. The alternatives to using epinephrine in a life-threatening situation may not be satisfactory. The presence of a sulfite(s) in this product should not deter administration of the drug for treatment of serious allergic or other emergency situations.

Epinephrine must be administered with great caution, if at all, in patients with cardiac arrhythmias, coronary artery or organic heart disease and hypertension. In patients with coronary insufficiency or ischemic heart disease, epinephrine may precipitate or aggravate angina pectoris as well as produce potentially fatal ventricular arrhythmias. Epinephrine should be administered only with great caution to elderly patients, those with diabetes mellitus, hyperthyroidism, or psychoneurotic disorders; also to those with long-standing bronchial asthma or emphysema if such individuals may also have degenerative heart disease, and to pregnant women (see Pregnancy). Patients with Parkinson’s disease may notice a temporary worsening of symptoms.

Chlorpheniramine: Chlorpheniramine should be used with extreme caution in patients with stenosing peptic ulcer, pyloroduodenal obstruction, prostatic hypertrophy, or bladder neck obstruction. These compounds have an atropine-like action and therefore should be used with caution in patients with a history of increased intraocular pressure, cardiovascular disease, or hypertension. The asthmatic patient should take the chlorpheniramine tablets with caution.

Precautions: Ana-Kit is not intended to be a substitute for medical attention or hospital care. The kit is designed to be compact and easy to carry, and to provide emergency treatment when medical care is not immediately available. Highly sensitive individuals should have the kit readily available at all times. Because of its small size it can be carried by outdoor sportsmen, golfers, gardeners, or any sensitive individual who may be exposed to stinging insects (wasps, hornets, yellow jackets, fire ants or bees) or other potentially life-threatening allergens. The drugs in the Ana-Kit, when used as directed immediately following exposure to an allergen, may prove life-saving. Certain changes in the emergency instructions and in the kit itself may be made by the doctor according to the needs of the patient. In all cases the physician should instruct the patient, and/or any other person who might be in a position to administer the epinephrine, in the proper use of the syringe and the other components of this kit.

Drug Interactions: Caution is indicated in patients receiving cardiac glycosides or mercurial diuretics, since these agents may sensitize the myocardium to beta-adrenergic stimulation and make cardiac arrhythmias more likely.

The effects of epinephrine may be potentiated by tricyclic antidepressants, sodium levothyroxine, and certain antihistamines, notably chlorpheniramine, tripelennamine, and diphenhydramine.

The cardiostimulating and bronchodilating effects of epinephrine are antagonized by beta-adrenergic blocking drugs, such as propranolol. The vasoconstricting and hypertensive effects are antagonized by alpha-adrenergic blocking drugs, such as phentolamine. Ergot alkaloids and phenothiazines may also reverse the pressor effects of epinephrine.

Diabetic patients receiving epinephrine may require an increased dose of insulin or oral hypoglycemic drugs.

Carcinogenesis, Mutagenesis, Impairment of Fertility: There are no data from either animal or human studies regarding the carcinogenicity or mutagenicity of epinephrine or chlorpheniramine, and no studies have been conducted to determine their potential for the impairment of fertility.

Pregnancy: Teratogenic Effects. Epinephrine has been shown to be teratogenic in rats and hamsters at dose levels hundreds of times as high as the maximal human dose. Although there are no adequate or well-controlled studies in pregnant women, epinephrine crosses the placenta and its use during pregnancy may cause anoxia in the fetus. Epinephrine should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Children: Administered epinephrine or chlorpheniramine with caution to infants and children (see Dosage). Syncope has occurred following the administration of epinephrine to asthmatic children.

Adverse Reactions: Epinephrine: Adverse reactions include transient, moderate anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and respiratory difficulties. These symptoms occur in some persons receiving therapeutic doses of epinephrine, but are more likely to occur, or to occur in exaggerated form, in those with hypertension or hyperthyroidism. Excessive doses cause acute hypertension. Arrhythmias, including fatal ventricular fibrillation, have been reported, particularly in patients with underlying cardiac disease or those receiving certain drugs (see Drug Interactions).

Rapid rises in blood pressure have produced cerebral hemorrhage, particularly in elderly patients with cerebrovascular disease. Angina may occur in patients with coronary-artery disease.

Chlorpheniramine: Drowsiness, dizziness, blurred vision, dry mouth and gastrointestinal upsets may occur.

Occupational Hazards: Patients should not drive or operate machinery after taking chlorpheniramine. Large doses produce CNS depression and occasionally tremors or convulsions.

Reports of hematological disorders are rare.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: Epinephrine: Epinephrine is rapidly inactivated in the body, and treatment is primarily supportive. If necessary, pressor effects may be counteracted by rapidly acting vasodilators or alpha-adrenergic blocking drugs. If prolonged hypotension follows such measures, it may be necessary to administer another pressor drug, such as levarterenol.

Overdosage of epinephrine may produce extremely elevated arterial pressure, which may result in cerebrovascular hemorrhage, particularly in elderly patients.

If an epinephrine overdose induces pulmonary edema that interferes with respiration, treatment consists of a rapidly acting alpha-adrenergic blocking drug such as phentolamine and/or intermittent positive-pressure respiration.

Epinephrine overdosage can also cause transient bradycardia followed by tachycardia, and these may be accompanied by potentially fatal cardiac arrhythmias. Ventricular premature contractions may appear within 1 minute after injection and may be followed by multilocal ventricular tachycardia (prefibrillation rhythm). Subsidence of the ventricular effects may be followed by atrial tachycardia and occasionally by atrioventricular block. Treatment of arrhythmias consists of administration of a beta-adrenergic blocking drug such as propranolol.

Overdosage sometimes also results in extreme pallor and coldness of the skin, metabolic acidosis, and kidney failure. Suitable corrective measures must be taken.

Chlorpheniramine: Overdose symptoms may be sedation, apnea, cardiovascular collapse to stimulation, insomnia, hallucinations, tremors or convulsions. Also there may be dizziness, tinnitus, ataxia, blurred vision, hypotension, dry mouth, flushing and abdominal symptoms.

The patient should be induced to vomit, preferably with ipecac syrup and large amounts of water. Prevent aspiration of vomitus. Gastric lavage may be necessary using activated charcoal and saline. Hyperosmotic cathartics such as Milk of Magnesia may hasten elimination of residual cling. Vasopressors can be used to correct hypotension. Diazepam may be used to control seizures. Hyperpyrexia can be treated with cool sponges or a hypothermic blanket.

Dosage And Administration: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use Epinephrine Injection if it has a pinkish or darker than slightly yellow color or contains a precipitate.

The physician who prescribes the Ana-Kit should review the package insert in detail with the patient. This review should include the proper use of the 2-dose epinephrine syringe to insure that s.c. or i.m. injections are given into the deltoid region of the arm or the anteriolateral aspect of the thigh. See also Information for the Patient.

Epinephrine: For s.c. or i.m. injection only.

Adults and children over 12 years: 0.3 mL; 6 to 12 years: 0.2 mL; 2 to 6 years: 0.15 mL; Infants to 2 years: 0.05 to 0.1 mL.

When syringe is properly set up, as directed in the Patient Directions (see Information for the Patient), a 0.3 mL dose is administered when plunger is pushed until it stops. Syringe barrel has 0.1 mL graduations so that smaller doses can be measured. (Operation of syringe is explained in the Patient Directions For Use – see Information for the Patient.)

If after 10 minutes from the first injection symptoms are not noticeably improved, administer a second dose of epinephrine from the syringe.

Chlorpheniramine: Tablets are chewable antihistamines. Adults and children over 12 years: 4 tablets; children 6 to 12 years: 2 tablets; children under 6 years: 1 tablet.

Availability And Storage: Each kit contains: 1 syringe containing 2 single doses of epinephrine USP 1:1 000; 4 tablets of chlorpheniramine maleate USP 2 mg; 2 sterilizing swabs of isopropyl alcohol 70 %; 1 tourniquet and complete instruction sheet. Epinephrine injection contains sodium bisulfite. Store at room temperature (approximately 25°C).

ANA-KIT® Bayer Epinephrine – Chlorpheniramine Maleate Allergy Therapy

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