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Drug Caution Code - Code X




Code X: S.O.S.

May present certain problems; consult your pharmacist for specific instructions.

Code X refers to:
Acetaminophen
Ibuprofen
Loperamide
H2 receptor antagonists: Famotidine, Ranitidine
Topical preparations: Hydrocortisone, Antibiotics and antifungals, Vaginal anti-fungals

Acetaminophen

Acetaminophen is an effective antipyretic and analgesic that is relatively free of side effects at recommended doses. It does not interfere with uric acid secretion, does not affect acid-base balance, does not interfere with hemostasis and does not interfere with platelet aggregation. Thus it is useful where ASA is cautioned.

Chronic high doses of acetaminophen can increase the effect of warfarin. Patients on Coumadin should not take more than 2g daily for no more than a few days at a time.

Acetaminophen can cause adverse effects in people with asthma, but less so than ASA.

Short-term use of recommended doses are considered safe in pregnancy and lactation.

Chronic use of large doses (more than 5 g. daily for several weeks in adults or 150 mg/kg/day for 2 to 4 days in children) has been associated with hepatotoxicity. Also, alcoholics, patients with liver disease, the malnourished, and patients taking drugs that induce hepatic microsomal enzymes (phenobarbital, primidone, rifampin) may be at increased risk for hepatic toxicity. Renal damage is also associated with overdose.

Nausea, vomiting, weakness and abdominal pain are the early signs of toxicity, occuring within 2 to 3 hours. There is a latent period of 24 to 36 hours before the onset of symptoms of hepatic toxicity. Antidotal therapy with acetylcysteine is most effective within 10 hours following acetaminophen overdose.

Patient Counselling for Acetaminophen:

1. Do not take more than the recommended dose stated on the package. Liver damage can occur at higher doses.
2. Children up to 12 years old should not take more than 5 doses a day for more than 5 days in a row. Adults should not take for more than 10 days in a row.
3. If your pain and/or fever are not relieved within a few days, consult your doctor.
4. Keep in a safe place out of the reach of children. If you suspect a child has taken an overdose, immediately phone your local hospital or Poison Control Center and take the child to the hospital.
5. Always seek immediate medical help if you have taken an overdose, even if you do not feel ill.
6. If a patient is at higher risk for hepatotoxicity, they are more likely to develop liver damage, often at lower doses, than people with normal livers.
7. Beware of "hidden" doses in other preparations such as cold, flu, sinus, backache, etc. products.

Ibuprofen

Ibuprofen is an NSAID. The side effects are less common and less severe than those with ASA. Nausea, vomiting, heartburn, stomach discomfort are the main side effects.

Patient Counselling for Ibuprofen

1. Do not combine with ASA or other NSAIDs.
2. Take with food or milk to decrease stomach upset.
3. Do not take if you have peptic ulcers, stomach bleeding, or any other stomach disorder.
4. People allergic to ASA or other NSAIDs may also be allergic to ibuprofen. Those with asthma and nasal polyps may be more sensitive.
5. Not recommended during pregnancy or breastfeeding.

Loperamide

The efficacy of any anti-diarrheal medication for the treatment of most cases of non-specific diarrhea is questionable. The preferred treatment consists of fluid and electrolyte replacement, nutritional therapy and if possible, elimination of the underlying cause of the diarrhea. The decreased intestinal motility with traveller's diarrhea may cause prolonged fever by slowing the expulsion of the infectious organism. Inhibition of peristalsis may also result in fluid retention in the bowel, which may aggravate and mask dehydration and depletion of electrolytes, especially in young children.

Patient Counselling for Loperamide:

1. Should not be used in children under 12 years unless directed by a physician. Contraindicated in children under 2 years.
2. Should not be used if there is fever over 38' C or if there is blood or mucus in the stools.
3. Appropriate fluid and electrolyte replacement is still important.
4. Do not take a missed dose. The initial dose of 4 mg. is effective in 50% of patients.
5. Do not take more than the maximum dose of 16 mg. daily. (Eight 2 mg. tablets)
6. Loperamide must not be used in acute ulcerative colitis or pseudomembranous colitis associated with broad-spectrum antibiotics.
7. Should not be used for more than 48 hours.
8. Try to determine the cause of the diarrhea and avoid masking a problem. For example someone who has travelled recently may have an intestinal infection and will require antibiotic therapy.

Histamine H2 Receptor Antagonists

Ranitidine and famotidine are new to the OTC market. They are heavily advertised but consumers are often not sure of how they should be used. They are indicated for the prophylaxis and treatment of heartburn, acid indigestion, and the sour stomach associated with hyperacidity. However, their maximum effect does not occur for 1 to 3 hours. Ulcer therapy should always be referred to a physician.

The increase in gastric pH due to decreased acid secretion has the potential to affect the bioavailability of other medications and dosage forms. For example, enteric coated tablets whose absorption is pH dependent may break down in the stomach instead of the intestine. Conversely, this increase in pH may prevent the degradation of acid-labile drugs such as ketoconazole.

There is a ranitidine-alcohol interaction which causes increased blood alcohol levels but the significance of this is not documented.

Patient Counselling for H2 Receptor Antagonists

1. Do not take antacids within 1/2 to 1 hour of histamine H2 receptor antagonists.
2. Do not take continuously for more than 2 weeks unless directed by a physician.
3. Do not take if you have trouble swallowing or have persistent abdominal pain. Consult a physician.
4. Consult a physician if your condition does not improve or worsens.

Topical Antibiotic Preparations

The pharmacist should ensure that the correct product is being chosen. An antibiotic should not be used for fungal infections (athlete's foot) or viral infections (cold sores). Topical antibiotics should not be used to treat an existing infection or on an area much larger than a 25c coin (23 mm). Swelling, heat, redness, pain and pus are signs of infection. The severity of these symptoms indicates the degree of infection and whether or not a patient should consult a physician. Topical antibiotics should not be used for more than 1 week. Consult a physician before using on infants. Sensitivity reactions to topical antibiotics can occur.

Vaginal Antifungal Preparations

A vaginal fungal infection should be referred to a physician for initial diagnosis. A patient can then choose a suitable product for treatment. Once a diagnosis has been made a patient can self-treat recurring infections. A patient who is pregnant, has abdominal pain or fever, or is under 12 years of age should be referred to a physician. Any infection that does not resolve after treatment or recurs more than three times in a year should also be referred to a physician.

Topical Hydrocortisone 0.5%

Non-prescription hydrocortisone can be used to treat minor skin irritations due to eczema or contact dermatitis from poison ivy, poison oak, soap, cosmetics, jewelry, diaper rash or scalp dermatitis. It will relieve redness, itchiness, swelling and discomfort. Topical hydrocortisone is contraindicated if there is any infection present, for potential skin cancer or if the rash is due to another disease. It should be used with caution in pregnancy, diabetes, tuberculosis, peptic ulcer and hypertension. Use on or near mucous membranes and on the face should be discouraged. Treatment should not last longer than 7 days. Children less than 2 years of age should be treated only on the advice of a physician. If the product has been recommended by a physician, tight fitting diapers and plastic pants should be avoided.













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