The three main attributes of drug quality are identity, strength, and purity. Drug safety monitoring mitigates adverse drug reactions caused by therapeutic drugs. It involves identifying expected and unexpected adverse reactions resulting from the use of medicines.
Medication quality assurance systems play a critical role in reaching treatment goals by ensuring the quality of essential medicines, helping to deliver effective treatments that lead to less illness, and resulting in health care savings that can be reinvested towards improving other aspects of health and wellness.
What is Preparation H?
Preparation H products are medications used to temporarily relieve swelling, burning, pain, and itching caused by hemorrhoids also called piles. Hemorrhoids can develop inside the rectum (internal hemorrhoids) or under the skin around the anus (external hemorrhoids). Nearly three out of four adults will have hemorrhoids from time to time
Preparation H contains phenylephrine, which belongs to a class of drugs known as sympathomimetic amines. It works by temporarily narrowing the blood vessels in the area. This effect decreases swelling and discomfort. Some products may also contain substances (such as cocoa butter, hard fat, mineral oil, shark liver oil) that form a protective barrier to prevent too much irritating contact with stool.
Preparation H is all about getting your butt feeling comfortable again. Preparation H products are formulated to protect, soothe, and relieve pain and irritation, mild or severe, day or night.
How do you use preparation H cream and ointment?
Preparation H is an over-the-counter product available at most pharmacies. Do not use this product without consulting your physician if:
• You have underlying health conditions, such as heart disease, high blood pressure, thyroid disease, diabetes, or problems with passing urine because of an enlarged prostate.
• You are pregnant or breastfeeding.
• You are on medications for depression.
• You are younger than 12 years.
For using preparation H:
• Clean the affected area gently using a cleansing wipe.
• Pat dry the area using a soft cloth or tissue.
• Open the tube and apply the contents generously to the lower portion of the anus.
• You may apply the ointment up to four times a day, especially at night, in the morning, or following a bowel movement that may exacerbate hemorrhoid symptoms.
• For applying in the lower anal canal, remove the cover from dispensing cap and attach the dispensing cap to the tube.
• Lubricate the dispensing cap well and gently insert it partly into the anus.
• Clean the cap well after each use and replace the cover.
How to use Preparation H Suppositories?
1. Before inserting, empty your bowel and bladder. Wash your hands and cleanse the affected area by patting or blotting with an appropriate cleansing wipe.
2. Remove the outer wrapper from the suppository. Avoid handling the suppository for too long or it will melt in your hands.
3. Lie on your side with your lower leg straightened out and your upper leg bent forward toward your stomach. Lift upper buttock to expose the rectal area.
4. Insert one suppository, pointed end first, with your finger until it passes the muscular sphincter of the rectum, about 1 inch in adults (if not inserted past the sphincter, the suppository may pop out).
Does Preparation H expire?
Yes, it can expire, the expiration date on Preparation H is the final day that the manufacturer guarantees the full potency and safety of a medication. Drug expiration dates exist on most medication labels, including prescription, over-the-counter (OTC), and dietary (herbal) supplements.
According to the FDA, drug expiration dates reflect the time period during which the product is known to remain stable, which means it retains its strength, quality, and purity when it is stored according to its labeled storage condition.
In the late 1970s, the United States Food and Drug Administration (FDA) mandated that all prescription and over-the-counter (OTC) medical products contain an expiration date. Expiration dates for medicines are often marked “EXP” and are printed on the label or stamped onto the medicine bottle or box.
However, a study conducted by the U.S. military shows that some medications could retain their potency up to one year after the expiration date has passed hence the practice of using Preparation H after its shelf life has passed.
Can you use expired Preparation H?
No, a lot of things can go wrong when you use expired Preparation H because the ingredients in the medication are no longer as effective as they once were. Improper treatment of hemorrhoids can cause bleeding. External hemorrhoids can cause thrombosis [blood clotting], which gives way to severe pain from hemorrhoidal strangulation.
In addition, using expired Preparation H exposes you to an increased risk of adverse events and side effects.
Preparation H side effects
Common side effects of Preparation H may include:
• Flushing (warmth, redness, or tingly feeling)
• Loss of appetite
• Feeling restless or excited (especially in children).
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Preparation H may cause serious side effects. Stop using Preparation H and call your doctor at once if you have:
• Fast, pounding, or irregular heartbeat
• Severe dizziness or nervousness
• Sleep problems (insomnia)
• Increased blood pressure–severe headache, blurred vision, pounding in your neck or ears.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What may interact with Preparation H?
Do not use Preparation H with any of the following medications:
• Dihydroergotamine, ergotamine, ergoloid mesylates, methysergide, or ergot-type medication
• MAOIS like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• Other stimulant medicines
Preparation H may also interact with the following medications:
• Medicines for blood pressure
• Medicines for mental depression
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.