What is Watson 385?

Watson 385 is a white colored, oval to elliptical shaped pill containing acetaminophen and hydrocodone bitartarate. Like other combinations of acetaminophen and hydrocodone, purpose of combining two drugs in a single tablet of Watson 385 is to provide safe and effective analgesic for management of moderate to severe pain. Watson 385 contains acetaminophen 500 mg and hydrocodone bitartarate 7.5 mg per tablet and this combination is prepared and marketed by Watson international pharmaceutical company in United States of America.

Mechanism of action of both the drugs contained in Watson 385 is different. Acetaminophen has several uses; it is an anti-pyretic and an analgesic. Pain killing effect of acetaminophen comes through inhibition of nitric oxide pathway. Inhibiting nitric oxide pathway reduces the production of neurotransmitters like substance P and N-methyl-D-aspartate which are main culprit in causing pain. Hydrocodone on the other hand is an opioid analgesic that relieves pain by activating some specific opioid receptors in central nervous system (brain and spinal cord). Due to different mechanism for relieving pain of both the drugs, Watson 385 proves to be more effective than either of the drugs contained in it.

Watson 385 is superior in gastric safety to commonly available group of drugs called NSAIDS (non-steroidal anti-inflammatory drugs for example diclofenac, naproxen, piroxicam, etc). Unlike NSIDS, Watson 385 does not cause inflammation, erosion and ulceration of stomach even on prolonged use. Although it is a safe remedy to control pain but its over dosage should be avoided especially in elderly population. Watson 385 has got an addiction potential and physical dependence so it should be used at minimum possible doses for the duration prescribed by the doctor. Safety of this drug is also not proven in pregnancy and breastfeeding so alternative drugs should be used in these conditions instead of using Watson 385.


What is this medicine for?

Watson 385 is an effective remedy in management of moderate to severe pain arising from muscles, bones, joints as well as soft tissues of the body. Gastric safety of Watson 385 makes it a preferred choice in conditions that need pain management over longer period of time. It can be used for short term, long-term and as per need basis. One thing should be kept in mind that use of Watson 385 at high doses for extended period of time may lead to addiction to this drug. Following are the conditions where Watson 385 is most commonly used,

  • Joint pain of osteoarthritis: it is a common complaint especially in elderly people and persons with joint destruction as a result of repeated trauma to the joints like knee and ankle injuries of footballers and other sports injuries. In these situations patients needs off and on pain-killers to remain pain free; a medicine like Watson 385 with gastric safety seems a proffered choice to be used in these conditions.
  • Joint pains in rheumatoid arthritis: rheumatoid arthritis is a chronic disease of joints that involves multiple small joints. Use of Watson 385 with non-steroidal anti-inflammatory drugs reduces the need for high dose of NSAIDS and associated side effects.
  • Watson 385 may be used in the pain management of Arthralgia /arthritis associated with systemic lupus erythmatosis, psoriatic arthritis, sero-negative arthropathies and others
  • Acute and chronic back pain may be managed with use of Watson 385
  • Headaches like migraine, tension headache and cluster headache may be ameliorated with Watson 385
  • Neuropathic pain like in diabetic neuropathy
  • Watson 385 is very effective in management of moderate to severe pain related to cancer and malignancies. It is used in palliative cancer therapy to control severe pain arising from distant spread of cancer.

Side effects on Watson 385

Watson 385 contains two drugs namely acetaminophen and hydrocodone so, side effect may arise from any of the two medicines. The most common side effects that a patient may experience with use of Watson 385 are,

  • Facial flushing
  • Blurring of vision
  • Constipation
  • Dizziness, drowsiness, increased sleep and light headedness. All these side effects are troublesome in early days of starting Watson 385 and settle gradually. Due to these side effects, Watson 385 should be used carefully in elderly population otherwise risk of fall and fracture increases.
  • Nausea and vomiting: again these are more severe initially and settle with the passage of time. If these side effects become troublesome then anti-emetic medicine may need to be taken with Watson 385. Another way to cope up with these side effects is to take Watson 385 with meals instead of taking it empty stomach.
  • Mood and mental changes may appear in some patients using Watson 385
  • Respiratory depression or difficulty in breathing may appear particularly on over dosage of Watson 385
  • Liver injury or liver damage is due to acetaminophen component of Watson 385 and particularly occurs on overdosing this drug or in patients with liver disease. Liver damage may range from mild to severe leading to liver failure.

Side effects of prolonged use of Watson 385

Some of the side effects of Watson 385 are related to its use over extended period of time. The side effects on prolonged use of Watson 385 are,

  • Prolonged use of Watson 385 may lead to physical dependence on the drug and patient feels persistent and irresistible craving to take drug. This may lead to addiction.
  • Analgesic abuse nephropathy leading to kidney failure may occur if Watson 385 is taken for 2-3 years at very high doses. This side effect is due to acetaminophen content of Watson 385.
  • Drug withdrawal is a problem in patients who use Watson 385 over prolonged period and suddenly stop the drug. Withdrawal symptoms include muscle rigidity, fever, tachycardia (increased heart rate), loose motions, hallucination (seeing objects, hearing voices or smelling something in the absence of any stimuli), insomnia or difficulty in sleeping, shivering, tremors, perspiration or increased sweating, etc.

Precautions 0n Watson 385

Use of Watson 385 should be done carefully in some conditions otherwise drug toxicity may occur, these conditions are,

  • Alcohol binging or drinking alcohol more than three drinks a day
  • Space occupying lesion of brain like brain tumor, brain abscess, etc.
  • head injury, depressed level of consciousness, hydrocephalus or other central nervous system disorders
  • kidney disease including renal failure and renal diseases with reduced kidney function
  • previous drug abuse or drug addiction
  • inflammatory bowel disease (IBD): ulcerative colitis or Crohn’s disease
  • heart disease or other cardiovascular problems
  • Liver disease acute and chronic hepatitis or cirrhosis of liver. Chances of hepatic encephalopathy increases in patients with decompensated cirrhosis of liver
  • Severe bronchial asthma, advanced lung disease, respiratory failure and breathing problems like obstructive sleep apnea
  • Lactating mother (the drug is secreted in breast milk and may affect baby)
  • Pregnancy or trying to conceive(it is a category C drug in pregnancy safety of which is not proven)
  • Suicidal tendency: suicidal ideation or previous suicidal attempt
  • Intestinal obstruction, recent gut surgery, BPH or benign prostatic enlargement and other disease of gut with chronic inflammation and ulceration

Also inform your doctor before starting Watson 385, if you are taking any other drugs including herbal medicine and other pain killers. Following drugs might have interactions with Watson 385,

  • Cimetidine and isoniazid which is enzyme inhibitors, using these medicines with Watson 385 leads to increased half life of Watson 385 and increased side effects. When it is necessary to use Watson 385 with these drugs, its dose should be reduced.
  • Naltrexone which is an anti-dote to hydrocodone so it may reduce the effectiveness of Watson 385
  • Using Watson 385 with alcohol, mono amine oxidase inhibitors, tricyclic anti-depressants, anti-psychotic drugs, muscle relaxants, phenobarbitol, ritonavir, sleeping pills and thiopental may lead to respiratory depression and deep coma so it should not be used with these drugs.
  • Other opioid analgesics like butorphanol, pentazocine, nalbuphine, tramadol and buprinorphine to avoid opioid over dosage
  • Other analgesic containing acetaminophen to avoid acetaminophen over dosage

Conditions that are not suitable for Watson 385 use

Watson 385 should not be used in certain conditions otherwise serious outcome may result. Following are the conditions that are not suitable for Watson 385 use,

  • Known allergy/hypersensitivity to Watson 385 or any of its content; acetaminophen or hydrocodone and other opioid analgesic
  • Watson 385 should not be used with muscle relaxants, sleep aid pills and drugs that depress conscious level otherwise deep coma may result
  • High risk professional like drivers and moving machinery operators should not use Watson 385 while on work. It causes sedation and dangerous accidents can occur due to reduced alertness
  • Patients who are alcohol bingers should not use Watson 385 as chances of deep coma and liver damage are increased
  • Elderly population is not suitable group of patients for Watson 385 use. It causes drowsiness, light-headedness and dizziness; all these factors increase chances of fall and risk of fractures.
  • Watson 385 is contraindicated in patients having liver cirrhosis (alcoholic cirrhosis and cirrhosis due to other diseases) and other severe liver damage (acute fulminant hepatic failure)
  • Watson 385 is contraindicated in organ failure like kidney failure, respiratory failure, advanced chronic obstructive pulmonary disease and other related conditions.
  • Patients having breathing or ventilatory problems should avoid Watson 385 for example, obstructive sleep apnea, severe bronchial asthma and others
  • Use of Watson 385 during pregnancy and breast-feeding is not safe. It crosses placenta as well as it is secreted in the breast milk so, bad effects may occur on babies.
  • Above mentioned are some of the conditions where use of Watson 385 is not appropriate. Anyone suffering from any of the above mentioned medical condition should inform his or her doctor before taking Watson 385.

Allergy symptoms of Watson 385

Allergy or hypersensitivity reaction to Watson 385 can be mild or life-threatening and usually occurs in patients who have known allergy to acetaminophen and hydrocodone. Hypersensitivity reaction should be reported to the doctor and no more Watson 385 pill should be taken after appearance of any the symptom of hypersensitivity.

Mild symptoms of allergy to Watson 385

Mild hypersensitive reaction or allergy to Watson 385 manifests as symptoms of itching, redness and hives over the skin. Difficulty in breathing or other life threateingin symptoms don’t appear on mild hypersensitivity. Mild allergy to Watson 385 usual settles on discontinuing the drug and administration of anti-histamine medicines like chlorphenaramine, citrizine, etc. Even mild allergy to Watson 385 is a contraindication to its subsequent use.

Severe allergy symptoms of Watson 385

Anaphylaxis or severe hypersensitivity reaction to Watson 385 can happen within minutes after taking this medicine particularly in patients who have hypersensitivity to Watson 385 or its contents. Anaphylaxis is fatal if not treated in time. Manifestations of severe hypersensitivity reaction to Watson 385 include,

  • Skin manifestations include itching, hives, urticaria and redness of skin
  • Hypotension or very low blood pressure
  • Increased heart rate or very low heart rate
  • Angioedema that manifests as facial, lips and throat swelling leading to difficulty in breathing. In some cases laryngeal swelling becomes so severe that airway is totally closed and if timely tracheostomy is not done lead to death.
  • Increased perspiration or sweating
  • Fear, anxiety and mood changes
  • Reduced urine out put or oliguria
  • Depressed level of consciousness leading to coma

Urgent medical attention is needed to save the life of the patient. Immediate contact with the emergency medical service should be made if patient develops the above mentioned symptoms. Management of severe allergic reaction to Watson 385 includes administration of anti-histamine, steroids and adrenaline. Supportive measures include cardiovascular support and respiratory support in critical conditions.

Dosage of Watson 385

Watson 385 should only be taken in dosage prescribed by the doctor to avoid untoward side effects. Dosage of the drug depends upon the severity of the pain and patients response to the drug. Usual starting dose for Watson 385 is one tablet every 6-8 hour. The dosage can be increased to one tablet every 4 hour but should not exceed 6 tablets per 24 hours. Watson 385 can be taken empty stomach or with meals with full glass of water. Patients who feel nausea and vomiting should take Watson 385 with meals to lessen these side effects.

If a dose of Watson 385 is missed

If a dose of Watson 385 is missed, it should be taken as soon as remembered but if time for next dose approaches, only usual next dose of the medicine should be taken no two doses should be taken together.

Over dosage of Watson 385

Watson 385 over dosage occurs in an attempt to get relief of severe pain by the patients. Elderly people are especially at risk of over dosage. Local poison control service or emergency medical service should be informed about over dosage. Patient should be managed in medical emergency/ICU. Symptoms of over dosage include,

  • Cyanosis (bluish discoloration of the skin)
  • Increased sleepiness that may lead to deep coma
  • Cheyne stroke breathing(irregular breathing pattern) or apnea(no breathing at all)
  • Excessive perspiration(sweating)
  • Cold and clammy skin
  • circulatory collapse(low blood pressure/hypotension)
  • Nausea or vomiting
  • Fits or convulsion
  • Symptoms of liver damage usual appear 24-72 hour after ingesting high dose of acetaminophen and include nausea, vomiting, yellow discoloration of eyes and depressed level of consciousness
  • Abdominal pain
  • Bilateral constricted pupils(pin point pupils)

Management of over dosage of Watson 385 should be carried in intensive care unit setting in anticipation for respiratory and circulatory collapse. The salient steps of over dosage management include,

  • Gastric lavage and decontamination with activated charcoal
  • Nalaxone administration to neutralize the effects of hydrocodone
  • N-acetyl cystine administration as an anti-dote to acetaminophen
  • Supportive measures like ventilatory support and ionotropic support for patients who have respiratory and circulatory collapse respectively.

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