Adult Dosing

Moderate to moderately severe pain

• 2 caps (712.8 mg/60 mg/32 mg) PO q4 hrs PRN
• Adjust the dose according to the severity of pain and the response of the patient

Pediatric Dosing

• Safety and effectiveness in pediatric patients 12 yrs have not been established

Moderate to moderately severe pain

• Children >12 yrs
• 2 caps (712.8 mg/60 mg/32 mg) PO q4 hrs PRN
• Adjust the dose according to the severity of pain and the response of the patient

[Outline]

• Adult Dosing
• Pediatric Dosing

• Relief of moderate to moderately severe pain

• Hypersensitivity to any of the ingredients of the product
• Aspirin triad
• Asprin or NSAID-induced asthma or urticaria
• Acute or severe asthma
• Severe respiratory depression
• Acute or severe hypercapnia
• Coagulation disorder
• GI bleeding
• Paralytic ileus
• Influenza, varicella, or febrile viral infections in patients <20 yrs
• Uncontrolled hypertension
• G6PD deficiency

• Respiratory depression and death have been reported in children receiving codeine after tonsillectomy and/or adenoidectomy. These patients had an evidence of being ultra-rapid metabolizers of codeine resulting from a CYP2D6 polymorphism

Renal Dose Adjustment

• Renal impairment: Caution advised, dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Caution advised, dose adjustments not defined

• Respiratory depression and death have been reported in children receiving codeine after tonsillectomy and/or adenoidectomy. These patients had an evidence of being ultra-rapid metabolizers of codeine resulting from a CYP2D6 polymorphism (US Black Box warning)
• Dihydrocodeine should be prescribed and administered with extreme caution as repeated use of dihydrocodeine may produce psychic dependence, physical dependence, and tolerance and therefore has the potential of being abused. Dihydrocodeine is subject to the provisions of the Federal Controlled Substances Act
• Use therapy cautiously in patients with peptic ulcer or coagulation abnormalities
• Dihydrocodeine may impair mental and/or physical abilities essential for performing potentially hazardous tasks such as driving a car or operating machinery; hence, patients should be cautioned accordingly
• Concomitant use with other narcotic analgesics, GA, tranquilizers, sedative-hypnotics, or other CNS depressants may produce an additive CNS depression; hence, reduce the dose of one or both agents when such combined therapy is contemplated

Cautions: Use cautiously in

• Renal impairment
• Hepatic impairment
• Elderly patients
• Debilitated patients
• CNS depression
• Alcohol abuse
• History of drug abuse

Synalgos-DC interacts with :

	Abiraterone
	Alka-Seltzer Plus Allergy
	Amiodarone
	Aplenzin
	Benadryl
	Benadryl Allergy
	Benadryl extra strength itch stopping
	Brisdelle
	Bupropion
	Children's Benadryl Allergy
	Cimetidine
	Cinacalcet
	Clobazam
	Cordarone
	Cymbalta
	Diphenhydramine
	Duloxetine
	Fluoxetine
	Forfivo XL
	Haldol
	Haloperidol
	Lamisil
	Lamisil AT
	Mellaril
	Mirabegron
	Myrbetriq
	Nexterone
	Norvir
	Nytol
	Onfi
	Pacerone
	Paroxetine
	Paxil
	Paxil CR
	PediaCare Children's Allergy
	Pexeva
	Propafenone
	Prozac
	Prozac Weekly
	Quinidex
	Quinidine
	Ritonavir
	Rythmol
	Rythmol SR
	Sarafem
	Selfemra
	Sensipar
	Simply Sleep
	Sominex Extra Strength
	Sominex Original
	Tagamet
	Tagamet HB
	Terbinafine
	Thioridazine
	Tranquil
	Unisom SleepGels
	Unisom SleepMelts
	Vicks ZzzQuil
	Wellbutrin
	Wellbutrin SR
	Wellbutrin XL
	Zyban
	Zytiga

Pregnancy Category:D (aspirin); C (caffeine); C (dihydrocodeine)

Breastfeeding: It is best to avoid aspirin during breastfeeding, especially with very young infants. As per some expert opinion, low dose aspirin (75-162 mg/day) may be used as an antiplatelet drug in nursing mothers; avoid chronic, high-dose aspirin. Avoid breastfeeding for 1-2 hours after a dose of aspirin to minimize antiplatelet effects in the infant. The risk of Reye's syndrome caused by salicylate in breastmilk is unknown. Caffeine appears in breastmilk rapidly after maternal ingestion. Adverse events like fussiness, jitteriness, and poor sleep patterns have been reported in the infants of mothers with very high caffeine intakes equivalent to 10 or more cups of coffee daily. No stimulatory effects on infants 3 wks were observed in mothers taking 5 cups of coffee daily. Preterm and younger newborn infants metabolize caffeine very slowly and may have serum levels of caffeine and other active caffeine metabolites similar to their mothers'. Decreased breastmilk iron concentrations causing mild iron deficiency anemia in some breastfed infants may occur on intake of >450 mL of coffee. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 5 December 2011). Based upon data from AAP Policy Guidelines, irritability and poor sleeping pattern may occur as caffeine is excreted slowly; no effects were observed with moderate intake of caffeinated beverages (2-3 cups per day). Information (available at http://aappolicy.aappublications.org/cgi/content/full/pediatrics;108/3/776 last accessed 5 December 2011).

• CNS: Lightheadedness, dizziness, drowsiness, sedation
• GI: Nausea, vomiting, constipation
• DERM: Pruritus, skin reactions, rash, diaphoresis
• MISC: Abuse dependency, Reye syndrome, salicylism

Aspirin

• Platelet aggregation inhibitor; inhibits prostaglandin synthesis, exhibits analgesic, anti-inflammatory activity; inhibits platelet aggregation by irreversible inhibition of platelet cyclooxygenase and thereby inhibiting the generation of thromboxane A2
• Rapidly and completely absorbed following oral administration
• Hydrolyzed in gut plasma (aspirin) and metabolized by liver (salicylic acid); CYP450: Unknown
• Excreted in urine
• Half-life: 15-20 minutes (aspirin), 2-6 hrs (salicylic acid)

Caffeine

• CNS stimulants; precise mechanism of action unknown; probably produces cerebral vasoconstriction and antagonizes adenosine A1 and A2 receptors
• Rapidly absorbed
• Metabolized by liver; CYP450: CYP1A2
• Excretion: Urine 70% (3% unchanged)
• Half-life: 3 hrs

Dihydrocodeine

• Semisynthetic narcotic analgesic; stimulates opiate receptors in CNS; also causes suppression of cough
• Metabolism: Liver; CYP450: 2D6, 3A4 substrate
• Excretion: Urine
• Half-life: 4 hrs

US Trade Name(s)

• Synalgos-DC

US Availability

Synalgos-DC (aspirin/caffeine/dihydrocodeine)

• CAPS: 356.4 mg/30 mg/16 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Analgesics

Analgesics; Combinations

Drug Name: Synalgos-DC (ASA 356 MG / caffeine 30 MG / dihydrocodeine 16 MG) Oral Capsule

Ingredient(s): Aspirin mixture with Caffeine and dihydrocodeine

Imprint: CP;419

Color(s): Blue, Gray

Shape: Capsule

Size (mm): 19.00

Score: 1

Inactive Ingredient(s): alginic acid / powdered cellulose / d&c red no. 28 / fd&c blue no. 1 / gelatin / ferrosoferric oxide / stearic acid / titanium dioxide

Drug Label Author:
Caraco Pharma Inc.

DEA Schedule:
CIII