Chloral Hydrate Syrup, USP contains chloral hydrate, an effective sedative and hypnotic agent for oral administration.

Each 5 mL (teaspoonful) contains:

In a clear, pink to orange colored, orange flavored syrup.

INACTIVE INGREDIENTS: Citric Acid, USP; D&C Yellow No. 10; FD&C Red No. 40; Flavor; Glycerin, USP; Liquid Sugar; Methylparaben, NF; Propylene Glycol, USP; Purified Water, USP; Sodium Benzoate, NF and Sodium Citrate, USP.

Chloral Hydrate is derived by combining a molecule of water with trichloroacetaldehyde (chloral).

Chemically, chloral hydrate is 1,1-Ethanediol, 2,2,2-trichloro-; its molecular formula is CCl₃CH(OH)₂ and its molecular weight is 165.4.

Chloral hydrate occurs as colorless or white, volatile, hygroscopic crystals very soluble in water and in olive oil and freely soluble in alcohol. It has an aromatic, pungent odor and a slightly bitter, caustic taste.

Last updated on RxList: 12/8/2004

Chloral hydrate is indicated for nocturnal sedation in all types of patients and especially for the ill, the young, and the elderly patient.

In candidates for surgery, it is a satisfactory preoperative sedative that allays anxiety and induces sleep without depressing respiration or cough reflex. In postoperative care and control of pain, it is a valuable adjunct to opiates and analgesics.

The syrup may be administered in a half glass of water, fruit juice, or ginger ale.

ADULTS

The usual hypnotic dose is 500 mg to 1 g, taken 15 to 30 minutes before bedtime or ½ hour before surgery. The usual sedative dose is 250 mg three times daily after meals. Generally, single doses or daily dosage should not exceed 2 g.

CHILDREN

The usual daily hypnotic dose is 50 mg/ kg of body weight, with a maximum of 1 g per single dose. Daily dosage may be given in divided doses if indicated. The sedative dose is half of the hypnotic dosage.

Chloral Hydrate Syrup, USP is supplied as a clear, pink to orange colored, orange flavored syrup containing 500 mg (7½ gr) in 5 mL (teaspoonful) in the following size:

16 fl oz (473 mL)

Storage

Store at controlled room temperature, 15°-30° C (59°-86° F).

AVOID EXCESSIVE HEAT

Dispense in tight, light- resistant containers as defined in the USP.

CAUTION: Federal law prohibits dispensing without prescription.

Last updated on RxList: 12/8/2004

Central Nervous System

Occasionally a patient becomes somnambulistic and he may be disoriented and incoherent and show paranoid behavior. Rarely, excitement, tolerance, addiction, delirium, drowsiness, staggering gait, ataxia, lightheadedness, vertigo, dizziness, nightmares, malaise, mental confusion and hallucinations have been reported.

Hematelogical

Leukopenia and eosinophilia have occasionally occurred.

Dermatological

Allergic skin rashes including hives, erythema, eczematoid dermatitis, urticaria, and scarlatiniform exanthems have occasionally been reported.

Gastrointestinal

Some patients experience gastric irritation and occasionally nausea and vomiting, flatulence, diarrhea, and unpleasant taste occur.

Miscellaneous

Rarely, headache, hangover, idiosyncratic syndrome, and ketonuria have been reported.

DRUG ABUSE AND DEPENDENCE

Controlled Substance

Drug Enforcement Administration Schedule IV.

Abuse

Chloral hydrate may be habit- forming. Patients known to be addiction- prone and patients who actively solicit hypnotics in increasing doses are potential addicts. Many patients take higher doses of hypnotics than they admit, and slurring of speech, incoordination, tremulousness, and nystagmus should arouse suspicion. Drowsiness, lethargy, and hangover are frequently observed from excessive drug intake.

Dependence

Prolonged use of larger than usual therapeutic doses may result in psychic and physical dependence. Tolerance and psychologic dependence may develop by the second week of continued administration.

Chloral hydrate addicts may take huge doses of the drug (i.e., up to 12 g nightly has been reported). This abuse is similar to alcohol addiction and sudden withdrawal may result in central nervous excitation, with tremor, anxiety, hallucination, or even delirium which may be fatal. In patients suffering from chronic chloral hydrate intoxication, gastritis is common and skin eruptions may develop. Parenchymatous renal injury may also occur. Withdrawal should be undertaken in a hospital and supportive treatment similar to that used during barbiturate withdrawal is recommended.

Chloral hydrate may cause hypoprothrombinemic effects in patients taking oral anticoagulants (See WARNINGS).

Administration of chloral hydrate followed by intravenous furosemide may result in sweating, hot flashes, and variable blood pressure including hypertension due to a hypermetabolic state caused by displacement of thyroid hormone from its bound state.

Caution is recommended in combining chloral hydrate with other CNS depressants such as alcohol barbiturates and tranquilizers. Administration of chloral hydrate should be delayed in patients who have ingested significant amounts of alcohol in the preceding 12 to 24 hours. CNS depressants are additive in effect and the dosage should be reduced when such combinations are given concurrently.

Last updated on RxList: 12/8/2004

Chloral hydrate may be habit-forming. Long-term use of larger than the usual therapeutic doses may result in psychic and physical dependence; therefore, caution must be exercised when administering the drug to patients susceptible to drug abuse. Sudden withdrawal may result in delirium. Chloral hydrate may increase the rate of metabolism of concomitantly administered coumarin or coumarinrelated anticoagulants, thus reducing their effectiveness. Upon withdrawal of chloral hydrate, the rate of metabolism of the anticoagulant drug may decrease with a concomitant rise in plasma levels and with the possibility of a gradual increase of anticoagulant effects (i.e., development of bleeding tendency and hemorrhage). Patients on oral anticoagulant therapy who are also taking chloral hydrate should have close observation of prothrombin times.

General

Chloral hydrate has been reported to precipitate attacks of acute intermittent porphyria and should be used with caution in susceptible patients. Continued use of therapeutic doses of chloral hydrate has been shown to be without deleterious effect on the heart. Large doses of chloral hydrate, however, should not be used in patients with severe cardiac disease (See CONTRAINDICATIONS).

Drug/ Laboratory Test Interactions

Chloral hydrate may interfere with copper sulfate tests for glycosuria (suspected glycosuria should be confirmed by a glucose oxidase test when the patient is receiving chloral hydrate), fluorometric tests for urine catecholamines (it is recommended that the medication not be administered for 48 hours preceding the test), or urinary 17-hydroxycorticosteroid determinations (when using the Reddy, Jenkins, and Thorn procedure).

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed.

Pregnancy Category C

Animal reproduction studies have not been conducted with chloral hydrate. Chloral hydrate crosses the placental barrier and chronic use during pregnancy may cause withdrawal symptoms in the neonate. It is not known whether chloral hydrate can affect reproduction capacity. Chloral hydrate should be given to a pregnant woman only if clearly needed.

Nursing Mothers

Chloral hydrate is excreted in human milk, use by nursing mothers may cause sedation in the infant.

Last updated on RxList: 12/8/2004

The signs and symptoms of chloral hydrate overdosage resemble those of barbiturate overdosage and especially affect the CNS and cardiovascular system. They may include: hypothermia; pinpoint pupils; blood pressure falls; comatose state; slow, or rapid and shallow breathing. Gastric irritation may result in vomiting and even gastric necrosis. If the patient survives, icterus due to hepatic damage and albuminuria from renal irritation may appear.

The toxic oral dose of chloral hydrate for adults is approximately 10 g; however, death has been reported from a dose of 4 g and some patients have survived after taking as much as 30 g.

Accidental overdosage should be treated with gastric lavage or by inducing vomiting to empty the stomach. Supportive measures may be used. Hemodialysis is reported to be effective in promoting the clearance of trichloroethanol.

Chloral hydrate is contraindicated in patients with marked hepatic or renal impairment and in patients with severe cardiac disease. Oral dosage forms of chloral hydrate are contraindicated in the presence of gastritis. Chloral hydrate is also contraindicated in patients who have previously exhibited an idiosyncrasy or hypersensitivity to the drug.

Last updated on RxList: 12/8/2004

The mechanism of action by which the Central Nervous System (CNS) is affected is not known. Chloral hydrate is readily absorbed from the gastrointestinal tract following oral administration; however, significant amounts of chloral hydrate have not been detected in the blood after oral administration. It is generally believed that the central depressant effects are due to the principal pharmacologically active metabolite trichloroethanol, which has a plasma half- life of 8 to 10 hours. A portion of the drug is oxidized to trichloroacetic acid (TCA) in the liver and kidneys; TCA is excreted in the urine and bile along with trichloroethanol in free or conjugated form.

Hypnotic dosage produces mild cerebral depression and quiet, deep sleep with little or no ''hangover''; blood pressure and respiration are depressed only slightly more than in normal sleep and reflexes are not significantly depressed, so the patient can be awakened and completely aroused. Chloral hydrate's effect on rapid eye movement (REM) sleep is uncertain. Chloral hydrate has been detected in cerebrospinal fluid and human milk, and it crosses the placental barrier.

Last updated on RxList: 12/8/2004

Chloral hydrate may cause gastrointestinal upset. The syrup should be diluted in half a glass of water or fruit juice.

Chloral hydrate may cause drowsiness; therefore, patients should be instructed to use caution when driving, operating dangerous machinery, or performing any hazardous task.

Patients should avoid alcohol and other CNS depressants. They should also be informed that chloral hydrate may be be habit-forming.

Chloral hydrate and all drugs should be kept out of the reach of children.

Patients should be warned against sudden discontinuation of chloral hydrate except under the advice of a Physician; they should also be informed of symptoms that would suggest potential adverse effects.

Last updated on RxList: 12/8/2004

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

CHLORAL HYDRATE - ORAL

(KLOR-ull HI-drate)

USES: This medication is used for a short time (no more than 2 weeks) to treat sleeping problems (insomnia). Chloral hydrate may also be used to calm you just before surgery or other procedures or to decrease anxiety from withdrawal from narcotics or barbiturates. It may also be used with other medications to decrease symptoms from alcohol withdrawal. It belongs to a class of drugs known as hypnotics. It works by affecting certain parts of the brain to cause calmness and sleep.

HOW TO USE: For sleep, take this medication by mouth with a full glass of water (8 ounces or 240 milliliters), 30 minutes before bedtime or as directed by your doctor. For other uses, take this medication 3 to 4 times daily as directed by your doctor. If you have severe heart disease, you should not take this medication more than 2 times daily. If using chloral hydrate solution, measure your dose using a medication-measuring spoon or device. Do not use a household spoon because you may not get the correct dose. Mix your dose with a full glass of water or other liquid (e.g., fruit juice, ginger ale) before taking it.

Dosage is based on your medical condition, and response to treatment. In children, the dosage is also based on weight.

If you are taking this medication for sleep, take it only when you need help falling asleep. Taking it regularly will make the drug work less well over time. Do not take more of this medication than prescribed. Doing so may increase side effects.

This medication may cause dependence, especially if it has been used regularly for an extended time or if it has been used in high doses. In such cases, withdrawal reactions may occur if you suddenly stop this drug. Withdrawal from chloral hydrate can be severe and may include sweating, trembling, anxiety, confusion, and hallucinations. To prevent withdrawal reactions when stopping extended, regular use with this drug, gradually reduce the dosage as directed. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.

Rarely, abnormal drug-seeking behavior (addiction) is possible with this medication. Do not increase your dose, take it more frequently, or take it for a longer time than prescribed. Properly stop the medication when so directed.

When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.

Tell your doctor if your condition persists or worsens.

SIDE EFFECTS: Stomach irritation, nausea, vomiting, bad taste in the mouth, and diarrhea may occur. Unwanted sleepiness and trouble waking up in the morning may occur. Less common side effects may include gas, persistent tiredness, headache, and nightmares. Stomach irritation can be reduced by taking chloral hydrate with a full glass of water. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., confusion, disorientation, thinking that others wish to harm you), staggering walk, lightheadedness.

Seek immediate medical attention if any of these rare but very serious side effects occur: severe dizziness, fainting, fast/irregular heartbeat.

Long-term use may cause persistent stomach irritation (gastritis), and a decrease in the amount of urine.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: See also How to Use section.

Before taking chloral hydrate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe kidney or liver problems.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: illegal drug use, alcoholism, mental/mood conditions (e.g., depression, thoughts of suicide), irritation of the swallowing tube (esophagus), stomach inflammation (gastritis), stomach ulcer, a certain blood/liver disease (porphyria), sleep apnea, certain heart problems (QT prolongation in the EKG, torsade de pointes).

This drug causes drowsiness. Do not drive, use machinery, or do any activity that requires alertness. Do not use alcoholic beverages while taking this medication. Doing so increases serious side effects (fast/sudden pounding heartbeat, flushing, unpleasant feeling of being high). Very severe (sometimes fatal) side effects from use with alcohol may also include inability to wake up and slowed breathing.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially stomach irritation.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug passes into breast milk. This can cause undesirable side effects in a nursing infant. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: See also Precautions section.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following medication because very serious interactions may occur: sodium oxybate.

If you are currently using the medication listed above, tell your doctor or pharmacist before starting chloral hydrate.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: furosemide given into a vein, warfarin.

Some other drowsiness-causing medications may cause serious (possibly fatal) slowed breathing when taken with chloral hydrate. Tell your doctor or pharmacist if you also take other drugs that cause drowsiness such as: other medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants (e.g., carisoprodol), narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone).

Some drugs may affect the heart rhythm (QTc prolongation in the EKG). QTc prolongation can infrequently result in a serious (rarely fatal) irregular heartbeat. Consult your doctor or pharmacist if you are taking disopyramide, amiodarone, quinidine, procainamide, flecainide, propafenone, sotalol, ibutilide, droperidol, bepridil, ziprasidone, dofetilide, cisapride, arbutamine, pimozide, among others. Ask for more details and for instructions on how you may reduce the risk of this effect.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting chloral hydrate.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: dizziness, vomiting, abdominal pain, fainting, inability to wake up, slowed breathing, bluish/cold skin.

NOTES: Do not share this medication with others. It is against the law.

Keep all medical appointments so that your doctor can monitor your progress or check for side effects.

Chloral hydrate may interfere with certain urine laboratory tests (certain sugar tests, catecholamines, 17-hydroxycorticosteroids). Make sure that all your doctors and laboratory personnel know that you are taking chloral hydrate.

MISSED DOSE: Usually, this medication should be taken only if needed.

If you are taking this medication on a regular basis and you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.