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ASIDOL-P
(10TX10S)
PARACETAMOL-325MG
TRAMADOL-37.5MG
ANALGESIC COMBINATION (OPOIDS)
ASIAN PHARMACEUTICALS-NAISA-DIVISION
Product Details
ACETAMINOPHEN
Class: Analgesic/antipyretic
Action Inhibits prostaglandins in CNS but lacks anti-inflammatory effects in periphery; reduces fever through direct action on hypothalamic heat-regulating center.
Indications Relief of mild-to-moderate pain; treatment of fever. Unlabeled use(s): Pain and fever prophylaxis after vaccination.
Contraindications Standard considerations.
ORAL
ADULTS: PO 325 to 650 mg prn q 4 to 6 hr or 1 g 3 to 4 times/day. Do not exceed 4 g/day. CHILDREN: PO 10 to 15 mg/kg dose prn q 4 to 6 hr; do not exceed 5 doses/24 hr.
SUPPOSITORIES
ADULTS: PR 650 mg q 4 to 6 hr; do not exceed 6 suppositories/24 hr. CHILDREN: 3–6 YR: PR 120 mg q 4 to 6 hr; do not exceed 720 mg/24 hr. CHILDREN: 6–12 YR: PR 325 mg q 4 to 6 hr; do not exceed 2.6 g/24 hr.
Ethanol: Chronic excessive use may increase risk of hepatotoxicity. Hydantoins, sulfinpyrazone: May decrease therapeutic effect of APAP; concomitant long-term use may increase risk of hepatotoxicity.
Lab Test Interferences With Chemstrip, bG Dextrostix, Visidex II home blood glucose measurement systems, drug may cause > 20% decrease in mean glucose.
HEMA: Hemolytic anemia; neutropenia; leukopenia; pancytopenia; thrombocytopenia. HEPA: Jaundice. OTHER: Hypoglycemia; allergic skin eruptions or fever.
Pregnancy: Category B. Lactation: Excreted in breast milk. Hepatic impairment: Chronic alcoholics should not exceed 2 g/day. Persistent pain or fever: May indicate serious illness. Physician should be consulted.
PATIENT CARE CONSIDERATIONS |
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- Administer with water 30 min before or 2 hr after meals.
- Store tablets and capsules at room temperature in tightly closed container. Refrigerate suppositories. Refrigeration of elixir improves palatability.
- Obtain patient history, including drug history and any known allergies.
- Assess for pain and fever before and 1 to 2 hr after administration.
- Assess serum glucose and liver enzyme levels before long-term therapy.
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- Instruct family to consult physician for use in children < 3 yr and, not to continue taking drug > 5 days unless advised by physician.
- Instruct adult patients not to continue taking drug > 10 days for pain or 3 days for fever.
- Instruct patient/family to contact physician if pain or fever (> 103°F) persists > 3 days.
- Advise diabetic patients to use sugar-free form of drug.
TRAMADOL HYDROCHLORIDE
(TRAM-uh-dole HIGH-droe-KLOR-ide) |
Ultram |
Class: Analgesic |
Action Binds to certain opioid receptors and inhibits reuptake of norepinephrine and serotonin; exact mechanism of action unknown.
Indications Relief of moderate to moderately severe pain.
Contraindications Acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic agents.
ADULTS & CHILDREN ³ 16 YR: PO 50–100 mg every 4–6 hr; maximum daily dose 400 mg. ELDERLY PATIENTS > 75 YR: PO 50–100 mg every 4–6 hr, maximum daily dose 300 mg. RENAL IMPAIRMENT: CRU < 30 ML/MIN. PO 50–100 mg every 12 hr (maximum 200 mg/day). CIRRHOSIS: 50 mg every 12 hours (maximum 100 mg/day).
Carbamazepine: May reduce serum tramadol levels, leading to decreased effectiveness. MAO inhibitors: Risk of seizures may be increased.
Lab Test Interferences None well documented.
CV: Vasodilation. CNS: Dizziness/vertigo; headache; somnolence; stimulation; anxiety; confusion; oordination disturbances; euphoria; nervousness; sleep disorder; seizures. DERM: Pruritus; sweating; rash. EENT: Visual disturbances; dry mouth. GI: Nausea; diarrhea; constipation; vomiting; dyspepsia; abdominal pain; anorexia; latulence. GU: Urinary retention/frequency; menopausal symptoms; increased creatinine; roteinuria. HEMA: Decreased hemoglobin. HEPA: Elevated liver enzymes. OTHER: Asthenia; hypertonia.
Pregnancy: Category C. Lactation: Excreted in breast milk. Children: Not recommended for children < 16 yr. Elderly: Patients > 75 yr-concentrations may be slightly elevated; may have less ability to tolerate adverse effects; use reduced dosage. Head trauma: Use with caution in patients with increased intracranial pressure or head trauma. Hepatic disease: Dosage adjustments may be required in patients with cirrhosis. Renal impairment: Dosage adjustments may be required. CNS depressants: Use with caution and in reduced dosage when administering to patients receiving CNS depressants. Opioid dependence: Not recommended for patients who are opioid-dependent; use caution when administering to patients who have recently received substantial amounts of opioids.
PATIENT CARE CONSIDERATIONS |
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- Can be taken without regard to meals.
- Administer medication before pain becomes severe.
- Store at room temperature, in a tightly closed container.
- Obtain patient history.
- Assess degree, location and characteristics of pain before administering.
- Assess vital signs before administering medication. If patient is hypotensive or dyspneic, notify physician before administering.
- Monitor I&O and check for urinary retention.
- Assess the effectiveness of the medication in relieving pain.
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- Instruct patient to take the prescribed dose at the recommended intervals.
- Inform patient to check with his/her healthcare provider first before taking any over-the-counter or prescription medications, including analgesics.
- Have patient report any serious side effects to the healthcare provider.
- Advise patient not to wait until pain level is high to self-medicate, because drug will not be as effective.
- Advise patient to avoid taking alcohol or other CNS depressants (g, sleeping pills).
- Advise the patient that this medication may cause drowsiness and to use caution while driving or using heavy equipment or performing other tasks requiring mental alertness.
- Advise patient to notify the healthcare provider if the pain is not relieved by the medication at the prescribed dosage.
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David S. Tatro
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