Active Pharmaceutical Ingredients Production – Acetaminophen

Pharmaceutical

Acetaminophen, known as Paracetamol by consumers all around the world, is a very famous active pharmaceutical ingredient that is often used for treating fever pain.

It can be given to the patient intravenously, rectally and the most popular form is orally. At times, it’s used to treat even cancer pain and other severe pains.

When taken in the doses recommended by the physician, it’s safe to use and its effects last 2-4 hours. It’s often the go-to drug for many, for fever.

Although the less severe effects of overdose are skin rashes, severe effects include liver failure.

It is available as a generic medication and under various brand names such as Mapap, Tylenol and others. It’s very popular in the UK and the USA, for treating pain and fever.

Uses of paracetamol

Pain – Consumption of paracetamol can help in achieving moderate to mild pain relief. The intravenous use of paracetamol is limited and is only used in cases of extreme emergencies.

Headache – Paracetamol is 39% more effective than any placebo (medication that has no physical effect on the patient but only makes them feel like they “are” taking a medication for treatment) medication, in the case of acute migraine. A first-line treatment for headache, is taking paracetamol with caffeine.

Low back pain – It does help in lower back pain, although this claim hardly has any backing even though the American Pain Society considers it as a first-line treatment.

Dental pain – Pills such as diclofenac and ibuprofen, prove to be more effective than paracetamol in the case of dental pain.

Fever – The dosage given to a child, should be based on his/her weight.

Side effects

Skin reactions – The FDA issued a warning in 2013 about the fatal conditions, such as Stevens–Johnson syndrome and toxic epidermal necrolysis (although they are rare even in the case of an overdose), that can be a result of paracetamol overdose.

Asthma – When respiratory infections were taken into account, the association of asthma with paracetamol was declined.

Although, children who are at a risk of developing of asthma, or children who suffer from asthma, should not consume paracetamol.

Liver damage – Fatal liver damage that can even lead to death, is one of the most severe effects of an overdose of paracetamol. Frequent alcohol consumption can increase the risks of overdose.

One of the top cause of acute liver failure, is overdose of paracetamol.

It increases the effect drastically, when it’s taken with alcohol because of which, the risks are much, much greater. In UK, US, New Zealand and Australia, most overdoses were of paracetamol.

Cancer – Paracetamol doesn’t affect bladder cancer but can increase kidney cancer.

Pregnancy – Paracetamol doesn’t affect pregnancy in animals.

When taken by a pregnant woman, paracetamol can increase the risks of ADHD (which develops later in life) and Asthma in the child.

For pain and fever although, paracetamol remains to be the first-line treatment for pregnant women, even after all these risks and controversies.

The way it works

It doesn’t directly inhibit the COX parts of brain but reduces COX, which needs to be oxidized for the functions to happen. How it works, is not known exactly as it doesn’t inhibit COX like NSAIDs.

Pharmacokinetics

Paracetamol is quickly absorbed by the gastrointestinal tract as soon as it is consumed. Paracetamol is mainly metabolized into toxic and non-toxic products in the liver.

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Controversy

According to a report, ProPublica claims that the FDA needs to establish the dangers held by paracetamol’s usage but Tylenol is opposing safety warnings, dosage restrictions and other measures. It is because these will lead into a fall of the sales of paracetamol which will not be beneficial for Tylenol, at all.

Effects on animals

As part of a chemical control program, Acetaminophen was used to control brown tree snake in Guam as the active pharmaceutical ingredient is lethal to them. This was done by using a to scatter 80mg dosage of paracetamol, into dead mice.

Cats who consume acetaminophen, do not die by liver diseases but by asphyxiation which is caused by methemoglobin formation. The initial symptoms are salivation, discoloration of gums and tongue and vomiting. It is due to the fact that they do not have the UGT1 enzyme required to break it down.

Before giving it to dogs for treating their musculoskeletal pain, veterinary doctors, or chemists should be consulted.

Summary

Any medication when taken in high dosage, can result in fatal adverse effects. This is why, paracetamol should only be taken in the recommended doses and after consulting from a physician.

It should be kept away from cats and snakes, and from children who suffer from asthma as a precautionary measure.

It is no doubt, one of the most important active pharmaceutical ingredient but should be taken with care, and not with alcohol has its effects are multiplied when done so.

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