Dolgic Plus

Dolgic Plus is part of the drug class:

• Anilides

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling sleepy.
• Belly pain.
• Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This combination drug product is intended as a treatment for tension headache.

It consists of a fixed combination of butalbital, acetaminophen and caffeine. The role each component plays in the relief of the complex of symptoms known as tension headache is incompletely understood.

Pharmacokinetics

The behavior of the individual components is described below.

Butalbital: Butalbital is well absorbed from the gastrointestinal tract and is expected to distribute to most tissues in the body. Barbiturates in general may appear in breast milk and readily cross the placental barrier. They are bound to plasma and tissue proteins to a varying degree and binding increases directly as a function of lipid solubility.

Elimination of butalbital is primarily via the kidney (59% to 88% of the dose) as unchanged drug or metabolites. The plasma half‑life is about 35 hours. Urinary excretion products include parent drug (about 3.6% of the dose), 5-isobutyl-5-(2,3-dihydroxypropyl) barbituric acid (about 24% of the dose), 5-allyl-5 (3-hydroxy-2-methyl-1-propyl) barbituric acid (about 4.8% of the dose), products with the barbituric acid ring hydrolyzed with excretion of urea (about 14% of the dose), as well as unidentified materials. Of the material excreted in the urine, 32% is conjugated.

The in vitro plasma binding of butalbital is 45% over the concentration range of 0.5 to 20 mcg/mL. This falls within the range of plasma protein binding (20% to 45%) reported with other barbiturates such as phenobarbital, pentobarbital, and secobarbital sodium. The plasma-to-blood concentration ratio was almost unity, indicating that there is no preferential distribution of butalbital into either plasma or blood cells. (See OVERDOSAGE for toxicity information.)

Acetaminophen: Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug. (See OVERDOSAGE for toxicity information.)

Caffeine: Like most xanthines, caffeine is rapidly absorbed and distributed in all body tissues and fluids, including the CNS, fetal tissues, and breast milk.

Caffeine is cleared through metabolism and excretion in the urine. The plasma half-life is about 3 hours. Hepatic biotransformation, prior to excretion, results in about equal amounts of 1-methylxanthine and 1-methyluric acid. Of the 70% of the dose that is recovered in the urine, only 3% is unchanged drug. (See OVERDOSAGE for toxicity information.)

Frequently Observed: The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling.

Infrequently Observed: All adverse events tabulated below are classified as infrequent.

Central Nervous System: headache, shaky feeling, tingling, agitation, fainting, fatigue, heavy eyelids, high energy, hot spells, numbness, sluggishness, seizure. Mental confusion, excitement or depression can also occur due to intolerance, particularly in elderly or debilitated patients, or due to overdosage of butalbital.

Autonomic Nervous System: dry mouth, hyperhidrosis.

Gastrointestinal: difficulty swallowing, heartburn, flatulence, constipation.

Cardiovascular: tachycardia.

Musculoskeletal: leg pain, muscle fatigue.

Genitourinary: diuresis.

Miscellaneous:pruritus, fever, earache, nasal congestion, tinnitus, euphoria, allergic reactions.

Several cases of dermatological reactions, including toxic epidermal necrolysis and erythema multiforme, have been reported.

The following adverse drug events may be borne in mind as potential effects of the components of this product. Potential effects of high dosage are listed in the OVERDOSAGE section.

Acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis.

Caffeine: cardiac stimulation, irritability, tremor, dependence, nephrotoxicity, hyperglycemia.

Following an acute overdosage of butalbital, acetaminophen and caffeine, toxicity may result from the barbiturate or the acetaminophen. Toxicity due to caffeine is less likely, due to the relatively small amounts in this formulation.

Signs and Symptoms

Toxicity frombarbiturate poisoning include drowsiness, confusion, and coma; respiratory depression; hypotension; and hypovolemic shock.

Inacetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necroses, hypoglycemic coma and coagulation defects may also occur. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.

Acute caffeine poisoning may cause insomnia, restlessness, tremor, and delirium, tachycardia and extrasystoles.

Treatment

A single or multiple drug overdose with this combination product is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended. Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption.

Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Assisted or controlled ventilation should also be considered

Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration.

Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication.

One tablet every four hours. Total daily dosage should not exceed 5 tablets.

Extended and repeated use of this product is not recommended because of the potential for physical dependence.

Dolgic Plus (butalbital, acetaminophen and caffeine tablets, USP), containing butalbital 50 mg (Warning: May be habit-forming), acetaminophen 750 mg and caffeine 40 mg are dark pink, oval shaped tablets with a convex face and are debossed “A 074” on one side.

They are supplied in bottles of 100, NDC 59630-074-10

Storage

Store at 20° to 25°C (68° to 86°F) [see USP Controlled Room Temperature].

PHARMACIST: Dispense in a tight, light-resistant container with a child-resistant closure.

Rx only

Manufactured by:

MIKART, INC.

Atlanta, GA 30318

Manufactured for:

SHIONOGI INC.

Florham Park, NJ 07932

Code 886F00

Rev. 08/13

Applies to acetaminophen / butalbital / caffeine: oral capsule, oral solution, oral tablet

Along with its needed effects, acetaminophen / butalbital / caffeine 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 immediately if any of the following side effects occur while taking acetaminophen / butalbital / caffeine:

• Lightheadedness
• shortness of breath

• Abdominal or stomach pain
• black, tarry stools
• bleeding gums
• blistering, peeling, or loosening of the skin
• blood in the urine or stools
• blurred vision
• change in the frequency of urination or amount of urine
• chills
• cough
• diarrhea
• difficulty with breathing
• difficulty with swallowing
• dizziness
• drowsiness
• dry mouth
• fainting
• fast, pounding, or irregular heartbeat or pulse
• flushed or dry skin
• fruit-like breath odor
• hives, itching, or skin rash
• increased hunger
• increased thirst
• increased urination
• joint or muscle pain
• loss of appetite
• nausea or vomiting
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• seizures
• shakiness in the legs, arms, hands, or feet
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• sweating
• swelling of the feet or lower legs
• tightness in the chest
• trembling or shaking of the hands or feet
• troubled breathing
• unexplained weight loss
• unusual bleeding or bruising
• unusual tiredness or weakness
• weakness

Get emergency help immediately if any of the following symptoms of overdose occur while taking acetaminophen / butalbital / caffeine:

• Confusion as to time, place, or person
• dark urine
• difficult or painful urination
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fever
• general feeling of discomfort or illness
• hallucinations
• headache
• holding false beliefs that cannot be changed by fact
• increased sweating
• irregular, fast or slow, or shallow breathing
• light-colored stools
• loss of appetite
• pale or blue lips, fingernails, or skin
• restlessness
• sudden decrease in the amount of urine
• sweating
• trouble sleeping
• unpleasant breath odor
• unusual excitement, nervousness, or restlessness
• vomiting of blood
• yellow eyes or skin

Some side effects of acetaminophen / butalbital / caffeine 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:

• Relaxed and calm
• sleepiness

• Anxiety
• bloated
• constipation
• continuing ringing or buzzing or other unexplained noise in the ears
• depression
• earache
• excess air or gas in the stomach or intestines
• false or unusual sense of well-being
• full feeling
• hearing loss
• heartburn
• heavy eyelids
• high energy
• hot spells
• hyperventilation
• irritability
• numbness
• pain in the leg
• passing gas
• sluggishness
• stuffy nose
• tingling sensation