Ativan Injection

Name: Ativan Injection

Description

Lorazepam, a benzodiazepine with antianxiety, sedative, and anticonvulsant effects, is intended for the intramuscular or intravenous routes of administration. It has the chemical formula: 7-chloro-5(2-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1, 4-benzodiazepin-2-one. The molecular weight is 321.16, and the C.A.S. No. is [846-49-1]. The structural formula is:

Lorazepam is a nearly white powder almost insoluble in water. Each mL of sterile injection contains either 2.0 or 4.0 mg of lorazepam, 0.18 mL polyethylene glycol 400 in propylene glycol with 2.0% benzyl alcohol as preservative.

How supplied

ATIVAN (lorazepam) Injection is available in the following dosage strengths in single-dose and multiple-dose vials:

2 mg per mL

NDC 60977-112-01, 25 x 1 mL vial,
NDC
60977-112-02, 10 x 10 mL vial

4 mg per mL

NDC 60977-113-01, 25 x 1 mL vial,
NDC
60977-113-02, 10 x 10 mL vial

For IM or IV injection.

Store in a refrigerator.

PROTECT FROM LIGHT.

Use carton to protect contents from light.

Manufactured by : Baxter Healthcare Corporation, Deerfield, IL 60015 USA, For Product Inquiry 1 800 ANA DRUG (1-800-262-3784).

Warnings

Use In Status Epilepticus

Management of Status Epilepticus

Status epilepticus is a potentially life-threatening condition associated with a high risk of permanent neurological impairment, if inadequately treated. The treatment of status, however, requires far more than the administration of an anticonvulsant agent. It involves observation and management of all parameters critical to maintaining vital function and the capacity to provide support of those functions as required. Ventilatory support must be readily available. The use of benzodiazepines, like ATIVAN Injection, is ordinarily only one step of a complex and sustained intervention which may require additional interventions (e.g., concomitant intravenous administration of phenytoin). Because status epilepticus may result from a correctable acute cause such as hypoglycemia, hyponatremia, or other metabolic or toxic derangement, such an abnormality must be immediately sought and corrected. Furthermore, patients who are susceptible to further seizure episodes should receive adequate maintenance antiepileptic therapy.

Any health care professional who intends to treat a patient with status epilepticus should be familiar with this package insert and the pertinent medical literature concerning current concepts for the treatment of status epilepticus. A comprehensive review of the

considerations critical to the informed and prudent management of status epilepticus cannot be provided in drug product labeling. The archival medical literature contains many informative references on the management of status epilepticus, among them the report of the working group on status epilepticus of the Epilepsy Foundation of America “Treatment of Convulsive Status Epilepticus” (JAMA 1993; 270:854-859). As noted in the report just cited, it may be useful to consult with a neurologist if a patient fails to respond (e.g., fails to regain consciousness).

For the treatment of status epilepticus, the usual recommended dose of ATIVAN Injection is 4 mg given slowly (2 mg/min) for patients 18 years and older. If seizures cease, no additional ATIVAN Injection is required. If seizures continue or recur after a 10- to 15- minute observation period, an additional 4 mg intravenous dose may be slowly administered. Experience with further doses of ATIVAN is very limited. The usual precautions in treating status epilepticus should be employed. An intravenous infusion should be started, vital signs should be monitored, an unobstructed airway should be maintained, and artificial ventilation equipment should be available.

Respiratory Depression

The most important risk associated with the use of ATIVAN Injection in status epilepticus is respiratory depression. Accordingly, airway patency must be assured and respiration monitored closely. Ventilatory support should be given as required.

Excessive Sedation

Because of its prolonged duration of action, the prescriber should be alert to the possibility, especially when multiple doses have been given, that the sedative effects of lorazepam may add to the impairment of consciousness seen in the post-ictal state.

Preanesthetic Use

AIRWAY OBSTRUCTION MAY OCCUR IN HEAVILY SEDATED PATIENTS. INTRAVENOUS LORAZEPAM AT ANY DOSE, WHEN GIVEN EITHER ALONE OR IN COMBINATION WITH OTHER DRUGS ADMINISTERED DURING ANESTHESIA, MAY PRODUCE HEAVY SEDATION; THEREFORE, EQUIPMENT NECESSARY TO MAINTAIN A PATENT AIRWAY AND TO SUPPORT RESPIRATION/VENTILATION SHOULD BE AVAILABLE.

As is true of similar CNS-acting drugs, the decision as to when patients who have received injectable lorazepam, particularly on an outpatient basis, may again operate machinery, drive a motor vehicle, or engage in hazardous or other activities requiring attention and coordination must be individualized. It is recommended that no patient engage in such activities for a period of 24 to 48 hours or until the effects of the drug, such as drowsiness, have subsided, whichever is longer. Impairment of performance may persist for greater intervals because of extremes of age, concomitant use of other drugs, stress of surgery, or the general condition of the patient.

Clinical trials have shown that patients over the age of 50 years may have a more profound and prolonged sedation with intravenous lorazepam (see also DOSAGE AND ADMINISTRATION, Preanesthetic).

As with all central-nervous-system-depressant drugs, care should be exercised in patients given injectable lorazepam as premature ambulation may result in injury from falling.

There is no added beneficial effect from the addition of scopolamine to injectable lorazepam, and their combined effect may result in an increased incidence of sedation, hallucination and irrational behavior.

General (All Uses)

PRIOR TO INTRAVENOUS USE, ATIVAN INJECTION MUST BE DILUTED WITH AN EQUAL AMOUNT OF COMPATIBLE DILUENT (see DOSAGE AND ADMINISTRATION). INTRAVENOUS INJECTION SHOULD BE MADE SLOWLY AND WITH REPEATED ASPIRATION. CARE SHOULD BE TAKEN TO DETERMINE THAT ANY INJECTION WILL NOT BE INTRA-ARTERIAL AND THAT PERIVASCULAR EXTRAVASATION WILL NOT TAKE PLACE. IN THE EVENT THAT A PATIENT COMPLAINS OF PAIN DURING INTENDED INTRAVENOUS INJECTION OF ATIVAN INJECTION, THE INJECTION SHOULD BE STOPPED IMMEDIATELY TO DETERMINE IF INTRA-ARTERIAL INJECTION OR PERIVASCULAR EXTRAVASATION HAS TAKEN PLACE.

Since the liver is the most likely site of conjugation of lorazepam and since excretion of conjugated lorazepam (glucuronide) is a renal function, this drug is not recommended for use in patients with hepatic and/or renal failure. ATIVAN should be used with caution in patients with mild-to-moderate hepatic or renal disease (see DOSAGE AND ADMINISTRATION).

Pregnancy

ATIVAN MAY CAUSE FETAL DAMAGE WHEN ADMINISTERED TO PREGNANT WOMEN. Ordinarily, ATIVAN Injection should not be used during pregnancy except in serious or life-threatening conditions where safer drugs cannot be used or are ineffective. Status epilepticus may represent such a serious and life-threatening condition.

An increased risk of congenital malformations associated with the use of minor tranquilizers (chlordiazepoxide, diazepam and meprobamate) during the first trimester of pregnancy has been suggested in several studies. In humans, blood levels obtained from umbilical cord blood indicate placental transfer of lorazepam and lorazepam glucuronide.

Reproductive studies in animals were performed in mice, rats, and two strains of rabbits. Occasional anomalies (reduction of tarsals, tibia, metatarsals, malrotated limbs, gastroschisis, malformed skull, and microphthalmia) were seen in drug-treated rabbits without relationship to dosage. Although all of these anomalies were not present in the concurrent control group, they have been reported to occur randomly in historical controls. At doses of 40 mg/kg orally or 4 mg/kg intravenously and higher, there was evidence of fetal resorption and increased fetal loss in rabbits which was not seen at lower doses.

The possibility that a woman of childbearing potential may be pregnant at the time of therapy should be considered.

There are insufficient data regarding obstetrical safety of parenteral lorazepam, including use in cesarean section. Such use, therefore, is not recommended.

Endoscopic Procedures

There are insufficient data to support the use of ATIVAN Injection for outpatient endoscopic procedures. Inpatient endoscopic procedures require adequate recovery room observation time.

When ATIVAN Injection is used for peroral endoscopic procedures; adequate topical or regional anesthesia is recommended to minimize reflex activity associated with such procedures.

Commonly used brand name(s)

In the U.S.

  • Ativan

Available Dosage Forms:

  • Solution

Therapeutic Class: Antianxiety

Pharmacologic Class: Benzodiazepine, Short or Intermediate Acting

Ativan Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common
  • Blue lips, fingernails, or skin
  • blurred vision
  • confusion
  • difficult or troubled breathing
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  • irregular, fast or slow, or shallow breathing
  • sleepiness or unusual drowsiness
  • sweating
  • unusual tiredness or weakness
Less common
  • Decreased awareness or responsiveness
  • not breathing
  • severe sleepiness
Rare
  • Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • bloody or cloudy urine
  • change in consciousness
  • convulsions
  • cough or hoarseness
  • deep or fast breathing with dizziness
  • delusions
  • dementia
  • difficult, burning, or painful urination
  • extremely shallow or slow breathing
  • fever or chills
  • frequent urge to urinate
  • headache
  • loss of consciousness
  • lower back or side pain
  • numbness of feet, hands and around mouth
  • painful or difficult urination
  • problems with movement, walking, or speech
  • vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Rare
  • Nausea

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Precautions

Before using lorazepam, tell your doctor or pharmacist if you are allergic to it; or to other benzodiazepines (such as alprazolam, clonazepam, diazepam); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor your medical history, especially of: glaucoma, heart disease, kidney disease, liver disease, personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), mental/mood disorders (such as depression, psychosis), breathing problems (such as asthma, chronic obstructive pulmonary disease-COPD, sleep apnea).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This drug may make you dizzy or drowsy or blur your vision. Alcohol or marijuana can make you more dizzy or drowsy. For at least 8 hours after receiving this drug, you should not get out of bed without help. Do not drive, use machinery, or do anything that needs alertness or clear vision until the effects of the medication wear off (at least 24 hours). Avoid alcoholic beverages. Talk to your doctor if you are using marijuana.

Older adults may be more sensitive to the side effects of this drug, especially loss of coordination and drowsiness. Also, the elderly may not experience relief of anxiety with lorazepam. It may have the opposite effect on the elderly, causing symptoms including mental/mood changes, sleeping problems, increase in sexual interest, or hallucinations. Loss of coordination, drowsiness, and sleeping problems can increase the risk of falling.

This drug may have an opposite effect on children, causing restlessness, shaking (tremors), or mental/mood changes (such as agitation, hallucinations).

Infants and children younger than 3 years using anesthesia or drugs for sedation (including lorazepam) for procedures/surgeries may be at risk for slower brain growth. Talk to the doctor about the risks and benefits of this medication.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Tell the doctor right away if you notice symptoms in your newborn baby such as slowed breathing, feeding problems, or constant crying. Consult your doctor for more details

This drug passes into breast milk. Consult your doctor before breast-feeding.

Interactions

See also Warning section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: clozapine, haloperidol, kava, loxapine, orlistat, sodium oxybate (also known as gamma hydroxybutyrate or GHB).

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is used with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana, other drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Does Ativan Vial interact with other medications?
  • Anxiety
  • Benzodiazepines
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