Acetaminophen; Caffeine; Dihydrocodeine Bitartrate (0028)
| Ingredients: |
Acetaminophen; Caffeine; Dihydrocodeine Bitartrate |
| Indications: |
Pain, moderate to severe |
| Pregnancy Category: |
B |
| FDA Approved: |
1986- 03- 01 |
| Classes: |
Analgesics, narcotic; Xanthine derivatives |
| Brand Names: |
Panlor DC
-
US
;
Panlor SS
-
US
;
|
| DEA schedules: |
Schedule III |
DESCRIPTION
|
| |
Each light aqua and bluish- green capsule contains:
Dihydrocodeine Bitartrate: 16 mg. ( WARNING: May be habit forming.)
- Molecular formula: C18 H23 NO3 ·C4 H6
- Molecular weight: 451.46
- Chemical name: 6- hydroxy- 3- methoxy- N- methyl- 4, 5, - epoxy- morphinan bitartrate
Acetaminophen: 356.4 mg
- Molecular formula: C8 H9 NO2
- Molecular weight: 151.16
- Chemical name: Acetamide, N - (4- hydroxyphenyl)- 4′- hydroxy- acetanilide
Caffeine: 30 mg
- Molecular formula: C8 H10 N4 O2
- Molecular weight: (anhydrous) 194.19
- Chemical name: 1H- Purine- 2, 6, - dione, 3, 7, - dihydro- , 1, 3, 7- trimethyl- 1, 3, 7- trimethylxanthine
Compal also contains the following active ingredients: Croscarmellose sodium. FD&C blue no. 1, FD&C green no. 3, gelatin,
silica gel, silicon dioxide, sodium lauryl sulfate, corn starch, titanium dioxide and zinc stearate.
|
CLINICAL PHARMACOLOGY
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| |
Dihydrocodeine is a semi- synthetic narcotic analgesic related to codeine, with multiple actions qualitatively similar to
those of codeine; the most prominent of these involve the central nervous system and organs with smooth muscle components.
The principal action of therapeutic value is analgesia.
Compal also contains acetaminophen, a non- opiate, non- salicylate analgesic, antipyretic and caffeine.
|
INDICATIONS AND USAGE
|
| |
For the relief of moderate to moderately severe pain.
|
CONTRAINDICATIONS
|
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Hypersensitivity to dihydrocodeine, codeine, or acetaminophen.
|
WARNINGS
|
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Usage in Ambulatory Patients
|
| |
Dihydrocodeine may impair the mental and/ or physical abilities required for the performance of potentially hazardous tasks
such as driving a car or operating machinery. The patient using Compal should be cautioned accordingly.
|
Interactions With Other Central Nervous System Depressants
|
| |
Patients receiving other narcotic analgesics, general anesthetics, tranquilizers, sedative- hypnotics or other CNS depressants
(including alcohol) concomitantly with Compal may exhibit an additive CNS depression. When such combined therapy is contemplated,
the dose of one or both agents should be reduced.
|
|
PRECAUTIONS
|
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General
|
| |
Compal should be given with caution to certain patients such as the elderly or debilitated.
|
Usage in Pregnancy
|
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Reproduction studies have not been performed in animals. There is no adequate information on whether this drug may effect
fertility in human males and females or has a teratogenic potential or other adverse effect on the fetus.
|
Usage in Children
|
| |
Since there is no experience in children who have received this drug, safety and efficacy in children have not been established.
|
|
DRUG INTERACTIONS
|
| |
The CNS- depressant effects of dihydrocodeine bitartrate may be additive with that of other CNS depressants. See WARNINGS .
|
ADVERSE REACTIONS
|
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The most frequently observed reactions include light- headedness, dizziness, drowsiness, sedation, nausea, vomiting, constipation,
pruritus, and skin reactions.
|
DRUG ABUSE AND DEPENDENCE
|
| |
Compal is subject to the provisions of the Controlled Substance Act, and has been placed in Schedule III.
Dihydrocodeine can produce drug dependence of the codeine type and therefor has the potential of being abused. Psychic dependence,
physical dependence, and tolerance may develop upon repeated administration of dihydrocodeine, and it should be prescribed
and administered with the same degree of caution appropriate to the use of other oral narcotic- containing medications.
|
OVERDOSAGE
|
| |
Dihydrocodeine
|
| |
Signs and Symptoms
|
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Serious overdose with Compal is characterized by respiratory depression (a decrease in respiratory rate and/ or tidal volume,
Cheyne- Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold
an clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest
and death may occur.
|
Treatment
|
| |
Primary attention should be given to the re- establishment of adequate respiratory exchange through provision of a patent
airway and the institution of assisted or controlled ventilation. The narcotic antagonist naloxone is s specific antidote
against respiratory depression which may result from overdosage or unusual sensitivity to narcotics including codeine. Therefore,
an appropriate dose of naloxone hydrochloride should be administered, preferably by the intravenous route and simultaneously,
with efforts at respiratory resuscitation. Since the duration of action of dihydrocodeine may exceed that of the antagonist,
the patient should be kept under continued surveillance and repeated doses of the antagonist should be administered as needed
to maintain adequate respiration.
An antagonist should not be administered in the absence of clinically significant respirator or cardiovascular depression.
Oxygen, intravenous fluids, vasopressors and other supportive measures should be employed as indicated.
|
Gastric emptying may be useful in removing unabsorbed drug.
|
Acetaminophen
|
| |
Signs and Symptoms
|
| |
In acute acetaminophen overdosage, dose- dependent, potentially fatal hepatic necrosis is the most serious adverse effect.
Renal tubular necrosis, hypoglycemic coma and thrombocytopenia may also occur. In adults, hepatic toxicity has rarely been
reported with acute overdosage of less than 10 g and fatalities with less than 15 g. Importantly, young children seem to be
more resistant than adults to the hepatotoxic effect of an acetaminophen overdose. Despite this, the measures outlined below
should be initiated in any adult or child suspected of having ingested an acetaminophen overdose.
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- 72 hours post- ingestion.
|
Treatment
|
| |
The stomach should be emptied promptly by lavage or by induction of emesis with syrup of ipecac. Patients' estimates of the
quantity of a drug ingested are notoriously unreliable. Therefore, if an acetaminophen overdose is suspected, a serum acetaminophen
assay should be obtained as early as possible, but no sooner than 4 hours following ingestion. Liver function studies should
be obtained initially and repeated at 24 hour intervals.
The antidote, N- acetylcysteine, should be administered as early as possible, preferably within 16 hours of the overdose ingestion
for optimal results, but in any case within 24 hours. Following recovery there are no residual, structural or functional hepatic
abnormalities.
|
|
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DOSAGE AND ADMINISTRATION
|
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Dosage should be adjusted according to the severity of the pain and the response of the patient. Compal is given orally. The
usual adult dose is 2 capsules every 4 hours as needed for pain.
Store at controlled room temperature, 15- 30°C (59- 86°F). Protect from moisture. Dispense in a tight, light- resistant container.
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PRODUCT IDENTIFICATION
|
| |
None Available |
PRODUCT LISTING - RATED THERAPEUTICALLY EQUIVALENT
|
| |
| capsule - oral - 356.4 mg- 30 mg- 16 mg -
|
| 100.0 |
$88.13 |
Panlor DC
Pamlab LLC
|
00525001601 |
| tablet - oral - 712.8 mg- 60 mg- 32 mg -
|
| 100.0's |
$118.66 |
Panlor SS
Pamlab LLC
|
00525003201 |
| 500.0's |
$534.01 |
Panlor SS
Pamlab LLC
|
00525003205 |
|
PRODUCT LISTING - EQUIVALENTS NOT AVAILABLE
|
| |
| capsule - oral - 356.4 mg- 30 mg- 16 mg -
|
| 30.0 |
$15.27 |
Panlor DC
Physicians Total Care
|
54868277500 |
| tablet - oral - 712.8 mg- 60 mg- 32 mg -
|
| 100.0's |
$124.89 |
Panlor SS
Pamlab LLC
|
00525003210 |
| 500.0's |
$489.91 |
Panlor SS
Pamlab LLC
|
00525003250 |
|
|